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  5. Pharmalab Enterprises, Inc. - 588432 - 12/10/2019
  1. Warning Letters

WARNING LETTER

Pharmalab Enterprises, Inc. MARCS-CMS 588432 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Albert J. Perez, Jr.
Recipient Title
President
Pharmalab Enterprises, Inc.

3795 W 18th Ave.
Hialeah, FL 33012
United States

Issuing Office:
Office of Pharmaceutical Quality Operations, Division II

United States


December 10, 2019

Case # 588432

Warning Letter

 

Mr. Perez:

The U.S. Food and Drug Administration (FDA) inspected your drug and dietary supplement manufacturing facility, Pharmalab Enterprises, Inc., FEI 3004797270, at 3781 W 18th Ave., Hialeah, Florida, from May 29 to June 17, 2019.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

In addition, your Rabano Yodada with Noni and Vitamins product is adulterated within the meaning of section 402(g)(1) of the FD&C Act, 21 U.S.C. 342(g)(1), because we have identified serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, 21 CFR Part 111.

Your Aloe, Vitamin C, Ginger, and Honey Syrup, Compuesto Vegetal Clasico Ladra Miller, Compuesto Vegetal Quisqueyano Syrup, Rabano Yodada with Noni and Vitamins, Rabano Yodado De "El Salvador," Apetol, Broncolito for Children, BroncoMiel Syrup, Bronkisan-Miel with Eucalyptus and Propolis, Compuesto Vegetal Clasico Ladra Miller, Collagen, Emulsion de Escocia Cherry Flavor, and Vino Carne Hierro products are misbranded dietary supplements under section 403 of the FD&C Act, 21 U.S.C. 343, because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101.

Your Sureo Oral flavored and Leolyte flavored products are misbranded foods under section 403 of the FD&C Act, 21 U.S.C. 343, because they do not comply with the labeling requirements for food as required by 21 CFR 101.

We acknowledge receipt of your responses to our Form FDA 483.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

CGMP Violations

1. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Your firm contract manufactures over-the-counter (OTC) drug products (e.g., Rompe Pecho) which are marketed to children and adults. The microbial specification limits established for Rompe Pecho drug products lack adequate scientific justification.

Your established limit for total aerobic microbial plate count is not more than (NMT) (b)(4) cfu/mL, and total combined yeast and mold count is NMT (b)(4) cfu/mL for your drug products. These are far in excess of appropriate limits for drug products intended for oral use. Our inspection revealed 12 Rompe Pecho lots that had high aerobic microbial plate counts ranging from 220 cfu/mL to 2,800 cfu/mL.

In your response, you maintained the (b)(4) cfu/mL specification limit and retested some of your Rompe Pecho lots that were identified with high microbial counts. Your response is inadequate because you did not demonstrate that the established specification limits for these drug products are appropriate for their intended use. Your firm failed to provide a comprehensive risk-based assessment of your drug products’ raw material composition, manufacturing process and controls, and intended product use when determining your microbial specifications.

In response to this letter, provide the following:

• A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed corrective action and preventive action (CAPA) plan to remediate and provisions for evaluating its effectiveness. If a contract facility will be performing any laboratory functions on your behalf, conduct the same comprehensive assessment, implement an appropriate supplier CAPA, and provide a summary of your activities.
• A comprehensive assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards.
• A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination.
• Complete investigations into all batches with potential objectionable microbial contamination or an out-of-specification (OOS) microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.
• Appropriate microbiological batch release specifications (i.e., total counts, objectionable microorganisms obtained from identification of bioburden) for each of your drug products.
• All microbial test methods used to analyze each of your drug products.
• A summary of results from testing retain samples of all drug product batches within expiry. Test all appropriate quality attributes including, but not limited to, microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls.

2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Excessive Levels of Microbial Contamination

Your firm failed to perform adequate investigations concerning high microbial counts in your drug products.

For example, your total aerobic microbial count tests for Rompe Pecho CF lots 18L258 and 18L268 were 1,900 cfu/mL and 2,800 cfu/mL, respectively. You subsequently sent additional samples from each lot to two contract testing laboratories for microbial analysis. Your firm distributed these lots.

In your response, you stated that the additional testing yielded lower plate counts. Your response is inadequate because additional microbial testing cannot be relied upon as sole justification to release drug product batches, as contamination is not uniformly distributed in a system and any given sample may not be representative of the type or level of contamination. In addition, your investigation into the high microbial counts was inadequate. Your firm did not identify the root cause for the high microbial counts or provide evidence that you extended an investigation to other related batches.

Insufficient Antimicrobial Effectiveness Studies

Additionally, you lacked sufficient assurance of antimicrobial effectiveness of your various multi-use drug product formulations. Notably, upon your review of the findings of antimicrobial effectiveness testing (AET) studies performed in 2018 on the already-marketed Rompe Pecho EX formulation, your firm concluded that the “(b)(4).” You subsequently changed the preservative formulation of Rompe Pecho EX and also determined that changes in preservative levels were needed in master formulas of your other Rompe Pecho products. However, your firm continued to lack sufficient antimicrobial effectiveness studies on your multi-use product formulations.

Your response did not provide AET studies for each of your Rompe Pecho formulations. Significantly, your firm identified high contamination levels in your products after you modified formulation preservative levels. This data underscores that preservative systems cannot be a substitute for good manufacturing practices, including but not limited to, an adequately designed and controlled production process.

Your response also failed to address any batches previously distributed with inadequately preserved formulations.

In response to this letter, provide a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Also address how your firm will ensure that all phases of investigations are appropriately conducted.

3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Your firm did not adequately validate the process and qualify the equipment used to manufacture your drug products. During the validation studies for multiple Rompe Pecho drug products, you failed to identify and adequately evaluate process variables such as blending speeds, in-process hold times, and temperatures. In addition, your firm doubled the active ingredient concentration of your Rompe Pecho MAX and Rompe Pecho CF drug products to “(b)(4).”

In your response, you updated your procedure to “(b)(4).” Your response is inadequate. You failed to provide evidence that you have identified and evaluated all variables that may impact the manufacturing process of your drug products, whether on a univariate basis or in combination. In addition, you have not provided scientific justification for doubling the active ingredient concentration in your Rompe Pecho MAX and Rompe Pecho CF drug products. You also did not address the impact of the increased concentration on your manufacturing processes.

In addition, your response stated that “(b)(4).” Your response is inadequate. You continue to manufacture drug products in an unacceptable state of control. Your plan to relocate does not resolve the products on the market that were distributed despite being manufactured under unvalidated conditions. Your response also does not clearly outline a commitment to perform process performance qualification (PPQ) studies at the new facility prior to distribution.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established.

Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.

See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.

In response to this letter, provide the following:

• A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
• Include your process performance protocol(s), and written procedures for qualification of equipment and facilities.
• A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to changes are justified, reviewed, and approved by your quality unit. Your change management program should also include provisions for determining change effectiveness.
• An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.
• A detailed status report on the process validation studies for all drug products that have been manufactured at your current facility. In addition, provide a detailed plan with timelines for the completion of process performance qualification studies at your future facility.

Adulterated Dietary Supplements

Based on the records collected during the inspection, we have reviewed and identified serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, 21 CFR Part 111. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the FD&C Act, 21 U.S.C. 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

The significant violations documented during the inspection include, but are not limited to, the following:

You did not establish product specifications for each dietary supplement that you manufacture for the identity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). For example, your Rabano Yodado with Noni & Vitamins product’s label states the product contains Riboflavin (Vitamin B-2) at 0.66 milligrams (mg) and Vitamin B-6 (Pyridoxine) at 0.33 mg. The finished product specifications for this product provided in your response which was received on July 22, 2019 did not contain strength specifications for Riboflavin (Vitamin B-2) and Vitamin B-6 (Pyridoxine) nor did it contain finished product specifications for identity and composition.

Once you have established the product specifications as required by 21 CFR 111.70(e), you must take specific actions to determine whether the specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75(c). Subset and skip-lot testing of finished dietary supplement products must be supported by a sound statistical sampling plan that documents the rationale to support any testing schedule in accordance with 21 CFR 111.75(c). You must also ensure any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of all activities relating to such specifications, in accordance with 21 CFR 111.95(b)(1).

Misbranded Dietary Supplements

Additionally, your Aloe, Vitamin C, Ginger, and Honey Syrup, Compuesto Vegetal Clasico Ladra Miller, Compuesto Vegetal Quisqueyano Syrup, Rabano Yodada with Noni and Vitamins, Rabano Yodado De "El Salvador," Apetol, Broncolito for Children, BroncoMiel Syrup, Bronkisan-Miel with Eucalyptus and Propolis, Compuesto Vegetal Clasico Ladra Miller, Collagen, Emulsion de Escocia Cherry Flavor, and Vino Carne Hierro products are misbranded dietary supplements under section 403 of the FD&C Act, 21 U.S.C. 343, because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101, as follows:

1. Your Aloe, Vitamin C, Ginger, and Honey Syrup, Compuesto Vegetal Clasico Ladra Miller, Compuesto Vegetal Quisqueyano Syrup, Rabano Yodada with Noni and Vitamins, and Rabano Yodado De "El Salvador" products are misbranded within the meaning of sections 403(s)(2)(A) and 403(q)(5)(F) of the FD&C Act, 21 U.S.C. 343(s)(2)(A) and 343(q)(5)(F), in that the labels fail to list the name of each dietary ingredient of the supplements that are described in section 201(ff) and the quantity of each such dietary ingredient, as required by 21 CFR 101.36. For example:

• Your Aloe, Vitamin C, Ginger, and Honey Syrup product label suggests that the product contains cat’s claw extract, and aloe extract. However, these dietary ingredients and their quantitative amounts by weight per serving are not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3).
• Your Compuesto Vegetal Clasico Ladra Miller product label suggests that the product contains menhaden fish oil (omega-3) and radish seed extract. However, these dietary ingredients and their quantitative amounts by weight per serving are not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3).
• Your Compuesto Vegetal Quisqueyano Syrup product label suggests that the product contains menhaden fish oil (omega-3). However, this dietary ingredient and its quantitative amount by weight per serving is not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3).

2. Your Aloe, Vitamin C, Ginger, Honey Syrup, Apetol, Broncolito for Children, BroncoMiel Syrup, Bronkisan-Miel with Eucalyptus and Propolis, Compuesto Vegetal Clasico Ladra Miller, Compuesto Vegetal Quisqueyano Syrup, Collagen, Emulsion de Escocia Cherry Flavor, Rabano Yodado with Noni and Vitamins, Rabano Yodado De "El Salvador," and Vino Carne Hierro products are misbranded within the meaning of section 403(q)(5)(F) of the FD&C Act, 21 U.S.C. 343 (q)(5)(F), in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. For example:

• Your Aloe, Vitamin C, Ginger, and Honey Syrup product label fails to list the serving size for each of the age groups indicated on the label which includes one teaspoon (5 mL) for children six to 12 years of age and one tablespoon (15 mL) for adults. If the product is for persons within more than one group, the quantitative amount and percent of Daily Value for each group shall be presented in separate columns in accordance with 21 CFR 101.36(b)(2)(iii)(E).
• Your Broncolito for Children and BroncoMiel Syrup and Rabano Yodado De "El Salvador" product labels declare Total Carbohydrate with an incorrect % Daily Value based on the amount per serving declared. The percent of Daily Value shall be calculated by dividing the quantitative amount by weight of each (b)(2)-dietary ingredient by the RDI as established in 101.9(c)(8)(iv), or the DRV as established in 101.9(c)(9) for the specified dietary ingredient and multiplying by 100, in accordance with 21 CFR 101.36(b)(2)(iii)(B).
• Your Bronkisan-Miel with Eucalyptus and Propolis product label fails to list the serving size for each of the age groups indicated on the label which includes one tablespoon (15 mL) for adults and one teaspoon (5 mL) for children six or more years of age. If the product is for persons within more than one group, the quantitative amount and percent of Daily Value for each group shall be presented in separate columns in accordance with 21 CFR 101.36(b)(2)(iii)(E).
• Your Compuesto Vegetal Quisqueyano Syrup product label fails to list the serving size for each of the age groups indicated on the label which includes one tablespoon (15 mL) once a day for adults, for children nine years to under 18 years of age to take two teaspoons (10 mL) once a day, and for children four years to under nine years of age to take one teaspoonful (5 mL) a day. If the product is for persons within more than one group, the quantitative amount and percent of Daily Value for each group shall be presented in separate columns in accordance with 21 CFR 101.36(b)(2)(iii)(E). Furthermore, the label declares magnesium with an amount of less than two percent of the Daily Value. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than two percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
• Your Collagen product label declares sodium and total carbohydrate with an amount of 5 mg (0% DV) and 1 g (0% DV), respectively. Dietary ingredients for which DRVs have been established must declare "Less than 1%" or "<1%" of the Daily Value when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the "% Daily Value" when rounded to the nearest percent is zero, in accordance with 21 CFR 101.36(b)(2) (iii)(C). Furthermore, the label lists sodium in the wrong order. Sodium, its quantitative amount by weight per serving, and percent of the daily value, must be listed after protein in accordance with 21 CFR 101.36(b)(2)(i)(B). Lastly, the column heading “%DV” must appear on the same line as the heading “Amount Per Serving” (21 CFR 101.36(b)(2)(iii)(A)) and the line below calories must be a hairline rule (21 CFR 101.36(e)(5)).
• Your Emulsion de Escocia Cherry Flavor product label declares sodium with an amount of 10 mg (0% DV). Dietary ingredients for which DRVs have been established must declare "Less than 1%" or "<1%" of the Daily Value when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the "% Daily Value" when rounded to the nearest percent is zero, in accordance with 21 CFR 101.36(b)(2)(iii)(C). Furthermore, the label lists sodium in the wrong order. Sodium, its quantitative amount by weight per serving, and percent of the daily value must be listed after thiamin in accordance with 21 CFR 101.36(b)(2)(i)(B).
• Your Vino Carne Hierro product label declares calcium and your Compuesto Vegetal Clasico Ladra Miller product label declares magnesium with amounts of less than 2 percent of the Daily Value. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
• Your Aloe, Vitamin C, Ginger, and Honey Syrup, Rabano Yodado with Noni and Vitamins, Rabano Yodado De "El Salvador," and Vino Carne Hierro product labels fail to express all percentages of Daily Value to the nearest whole percent as required by 21 CFR 101.36(b)(2)(iii)(C).
• Your Apetol product label appears to declare percent DVs based on the revised nutrition labeling regulation which became effective July 26, 2016, but the label fails to correctly declare folate and folic acid (21 CFR 101.9(c)(8)(iv)) and fails to declare added sugar as required by the revised regulation (21 CFR 101.9(c)(8)(iv) and 101.9(c)(6)(iii), respectively). Labels must comply with the revised labeling regulation by January 1, 2020, or January 1, 2021, depending upon the annual food sales of the manufacturer. If you choose to follow the new labeling regulation at this time, you must do so consistently. Furthermore, the label fails to express percent DVs to the nearest whole percent as required by 21 CFR 101.36(b)(2)(iii)(C).

3. Your Aloe, Vitamin C, Ginger, and Honey Syrup and Emulsion de Escocia Cherry Flavor products are misbranded with the meaning of section 403(f) of the FD&C Act, 21 U.S.C. 343(f), because your product labels contain information in two languages but do not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the FD&C Act to appear on the label must appear in the foreign language.

4. Your Aloe, Vitamin C, Ginger, and Honey Syrup, Compuesto Vegetal Clasico Ladra Miller, Broncolito for Children, BroncoMiel Syrup, and Bronkisan-Miel with Eucalyptus and Propolis products are misbranded within the meaning of section 403(i)(2) of the FD&C Act, 21 U.S.C. 343(i)(2), in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically:

• The Aloe, Vitamin C, Ginger, and Honey Syrup product label lists the ingredient aloe but that is not the standardized common name listed in the reference Herbs of Commerce.
• The Compuesto Vegetal Clasico Ladra Miller product label lists the ingredient DATEM but that is not the common or usual name of that ingredient.
• The Broncolito for Children, BroncoMiel Syrup, and Bronkisan-Miel with Eucalyptus and Propolis product labels declare the dietary ingredient elder but that is not the standardized common name listed in Herbs of Commerce.

5. Your Aloe, Vitamin C, Ginger, and Honey Syrup product is misbranded within the meaning of section 403(s)(2)(C) of the FD&C Act, 21 U.S.C. 343(s)(2)(C), because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

Misbranded Foods

In addition, your 33.8 and 21.1 ounce (oz) Suero Oral Fruit Flavor, Suero Oral Plus Blue Raspberry Flavor, Suero Bubble Gum, Leolyte Oral Maintenance Solution Apple flavor, and Leolyte Oral Maintenance Solution Fruit flavor products are misbranded foods under section 403 of the FD&C Act, 21 U.S.C. 343, because they do not comply with the labeling requirements for foods as required by 21 CFR 101, as follows:

1. Your 33.8 oz Suero Oral Fruit Flavor, Leolyte Oral Maintenance Solution Apple flavor, and Leolyte Oral Maintenance Solution Fruit flavor products are misbranded within the meaning of sections 403(a)(1) and 201(n) of the FD&C Act, 21 U.S.C. 343(a)(1) and 321(n), in that their labels are false or misleading because they fail to reveal the material fact that the identified flavors are artificially derived. As required by 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles, or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accompanied by the word(s) “artificial” or “artificially flavored,” in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., “artificial vanilla,” “artificially flavored strawberry,” or “grape artificially flavored.” Specifically, these products are made with natural and artificial flavors; however, the products’ statements of identity do not include the named characterizing flavor is artificial.

2. Your 33.8 and 21.1 oz Suero Oral Fruit Flavor, Suero Oral Plus Blue Raspberry Flavor, Suero Bubble Gum, Leolyte Oral Maintenance Solution Apple flavor and Leolyte Oral Maintenance Solution Fruit flavor products are misbranded within the meaning of section 403(i)(2) of the FD&C Act, 21 U.S.C. 343(i)(2), because the labels purport to be beverages containing juice due to explicit vignettes of fruits; however, the labels do not include a percent juice declaration in accordance with 21 CFR 101.30.

3. Your Leolyte Oral Maintenance Solution Apple flavored and Leolyte Oral Maintenance Solution Fruit flavor products are misbranded within the meaning of section 403(q) of the FD&C Act, 21 U.S.C. 343(q), in that the nutrition information (e.g. Nutrition Facts label) does not meet the requirements of 21 CFR 101.9 as the product labels fail to contain nutrition information. As these products are conventional foods, the presentation of nutrition information is required in accordance with 21 CFR 101.9.

Labeling Comments

We also offer the following comments:

1. Your Aloe, Vitamin C, Ginger, and Honey Syrup, Compuesto Vegetal Clasico Ladra Miller, Broncolito for Children, BroncoMiel Syrup, Bronkisan-Miel with Eucalyptus and Propolis, Calicio infantil with Matricaria, and Calicio infantil con Matricaria Vanilla Flavor product labels list the chemical preservatives sodium benzoate, methyparaben, polyparaben, and/or potassium sorbate but do not bear labeling stating that fact, in that the label fails to include a separate description of their function as a preservative in accordance with 21 CFR 101.22(j).

2. Your Collagen product label declares the amount of calories as 45 per serving, which does not correspond with the amounts of total carbohydrate and protein per serving. Calories must be calculated in accordance with 21 CFR 101.9(c)(1)(i).

3. Your Aloe, Vitamin C, Ginger, and Honey Syrup product label bears the footnote “For Adults or Children 6 or more years of age, Percent Daily Values are based on a 2,000 calorie diet.” The footnote language does not allow for “For Adults or Children 6 or more years of age.”

4. The statements of identity for your Sureo Oral flavored and Leolyte flavored products do not meet the requirements in 21 CFR 101.3(d) because they are either not parallel to the base of the package, they are not in a size reasonably related to the most prominent printed matter on the label, or both.

5. If the benzoic acid ingredient is used as a preservative in your Sureo Oral flavored and Leolyte flavored products, its function must be declared as required in section 403(k) of the FD&C Act and 21 CFR 101.22(j).

6. Your Leolyte Oral Maintenance Solution Apple flavor and Leolyte Oral Maintenance Solution Fruit flavor products include “oral maintenance solution” in the statement of identity. There are no medical requirements for such a product. Please determine whether this is an appropriate statement of identity.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence or the occurrence of other violations.

We note that, during a teleconference with you on October 3, 2019, we discussed the excessive microbial counts reported from your Rompe Pecho CF and EX drug products. After the teleconference, you indicated that you would not voluntarily recall your drug products. Subsequently, on October 9, 2019, we held a teleconference with the own label distributor, Efficient Laboratories, Inc., concerning the excessive microbial counts for these drug products. This firm also indicated they would not voluntarily recall these drug products.

The Center for Drug Evaluation and Research (CDER) issued a Safety Alert on October 11, 2019, concerning the potential safety hazard associated with your products (see https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-rompe-pecho-cough-syrup).

Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.

FDA may also withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer until the above violations are corrected. We may re-inspect to verify that you have completed your corrective actions.

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.

Your written notification should refer to Warning Letter Number above (Case #588432). Please electronically submit your signed reply on your firm’s letterhead to CDR John W. Diehl, M.S., Director, Compliance Branch, at john.diehl@fda.hhs.gov and orapharm2_responses@fda.hhs.gov.

If you have questions regarding the contents of this letter, please contact Mr. Mark Rivero, Compliance Officer, at (504) 846-6103 or mark.rivero@fda.hhs.gov.

Sincerely,
/S/

Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations, Division II

 

CC:
Renee Alsobrook, Chief
Department of Business and Professional Regulation
Division of Drugs, Devices and Cosmetics
Compliance and Enforcement
2601 Blair Stone Road
Tallahassee, Florida 32399-1047
 

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