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WARNING LETTER

Biomin Industries, Inc. MARCS-CMS 522767 —

Delivery Method:
UPS
Recipient:
Recipient Name
Mr. Carl E. Staley
Biomin Industries, Inc.

119 S River Dr
Tempe, AZ 85281-3010
United States

Issuing Office:
Denver District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Foods - Division IV West
6th Avenue and Kipling Street
P.O. Box 25087, Denver, CO 80225 

 
 

 

AMENDED WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
October 13, 2017                                                                                      HAF4W(DEN)-17-12-WL

Mr. Carl E. Staley, President
Biomin Industries, Inc.
119 S River Dr
Tempe, AZ 85281-3010
 
Dear Mr. Staley:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Biomin Industries, Inc., located at 119 S River Dr., Tempe, AZ 85281-3010 from March 1 through March 15, 2017. Based on our inspection and subsequent review of product labeling for the products you manufacture, package, and label, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
 
The significant violations documented during the inspection include, but are not limited to, the following:
 
Unapproved New Drug Violations
 
The FDA reviewed some of the product labels you use in your labeling operations that FDA collected during our inspection, including (b)(4) (b)(4) and (b)(4). The claims on these product labels establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, the introduction or delivery for introduction, or causing the delivery or introduction, of these products into interstate commerce for such uses violates the Act. 
 
Examples of some of the claims on the product labeling that provide evidence that these products are intended for use as drugs include:
  • (b)(4):
o   “(b)(4) designed to eliminate inflammation.”
  • (b)(4):
o   The name of the product and its similarity to “allergies”
  • (b)(4) Antibiotc:
o   The name of the product and its similarity to the drug category “antibiotic”
 
The products (b)(4), and (b)(4) Antibiotc are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Because no FDA approvals exist for (b)(4), and (b)(4) Antibiotc, introduction of these products into interstate commerce violates Section 301(d) of the Act [21 U.S.C. § 331(d)].
 
To the extent that your firm manufactures, packages, and labels products on behalf of another firm that releases for distribution that product under their firm’s name, your firm nevertheless has an obligation to know whether that product’s label and labeling is in conformance with the Act.  Although a firm may be under contract to perform certain manufacturing, packaging and labeling operations, it cannot contract out its ultimate responsibility to ensure that the products it places into commerce (or causes to be placed into commerce) comply with the Act. See United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). 
 
Accordingly, to the extent your firm purports to produce dietary supplements under contract for another firm, including performing labeling operations, you should establish a system to ensure that you are not producing drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] based on the labels placed on these products.
 
Dietary Supplement CGMP Violations
 
Even if the (b)(4), and (b)(4) Antibiotc products did not have therapeutic claims which make them unapproved new drugs, these products, and all dietary supplement products that you manufacture, including, but not limited to, the (b)(4) with Chromium Picolinate, (b)(4), and (b)(4) you manufacture, would be adulterated dietary supplements within the meaning of section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions which do not meet the Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
We have received your written response dated March 31, 2017, responding to our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on March 15, 2017. Our comments regarding your written response are detailed after the applicable violations, noted below, and we intend to verify the adequacy of that corrective action and other corrective actions at a future inspection.
 
During our inspection of your facility, our investigator observed the following significant violations:
 
1)    You failed to establish the following component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b):
  • Identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1);
  • Components specifications, for each component that you use in the manufacture of a dietary supplement, that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2); and
  • Establishing limits on those types of contamination that may adulterate, or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3).
Specifically, you stated in the signed affidavit that you use specifications provided by the supplier to compare to the certificate of analysis that comes with the ingredient, and that you do not establish component specifications for the ingredients used to manufacture the products.
 
Once component specifications have been established, you must determine whether they are met in accordance with 21 CFR 111.75(a).
 
We have reviewed your response received April 3, 2017. In your response you state that you will establish component specifications for approximately (b)(4) ingredients used to manufacture approximately (b)(4) finished products; however, we are unable to evaluate the adequacy of your response because you have not provided documentation that you have established component specifications.
 
2)    Your master manufacturing records (MMRs) for the (b)(4) Antibiotc and (b)(4) Capsules (b)(4) products fail to include the following information required by 21 CFR 111.210;
  • The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)];
  • Written instructions for procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
  • Written instructions for your manual operations to include one person adding the component and another person verifying the addition [21 CFR 111.210(h)(3)(ii)(B)]; and
  • Written instructions in your MMRs that include corrective action plans to use when a specification is not met [21 CFR 111.210(h)(5)].
We have reviewed your response, dated April 3, 2017. In your response you state that you have completed the correction for this issue and provided new MMRs for the (b)(4) Antibiotc and (b)(4) Capsules (b)(4) products as Attachments 5 and 6. However based on the documentation you provided, your MMRs are inadequate in that they have not met all the applicable requirements of 21 CFR 111.210 as stated above. For example, your MMRs for (b)(4) Antibiotic (Attachment 5 Page 5 of 10 Action 3) and (b)(4) Capsules (b)(4) (Attachment 6 Page 3 of 8 Action 3) fail to include provisions to document the initials of the person adding the components to the (b)(4) as well as provisions to document the initials of the person verifying the addition, as required by 21 CFR 111.210(h)(3)(ii)(B).  Your MMR for (b)(4) Capsules does not include the identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts Label, as require by 21 CFR 111.210(d).  For example, the product label for (b)(4) Capsules list plant cellulose and water as other ingredients, but you did not include these components in the ingredient list of the product’s MMR.  Finally, the MMRs for the (b)(4) Antibiotic and (b)(4) Capsules (b)(4) products do not include written instructions for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)], nor do they include corrective action plans to use when a specification is not met [21 CFR 111.210(h)(5)].
 
3)     You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, during the inspection our investigator observed that you did not have finished product specifications for the (b)(4) Antibiotc and (b)(4) Capsules (b)(4) products.
 
Once product specifications have been established you must determine whether they are met in accordance with 21 CFR 111.75(c), and you must make and keep records of such specifications in accordance with 21 CFR 111.95(b)(1).
 
We have reviewed your response, dated April 3, 2017. In your response you state it will take you approximately 4 months to complete this correction. However, you did not provide documentation to support that you have established product specifications; therefore, we are unable to evaluate the adequacy of your corrective action for this observation.
 
4)    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection our investigator observed you do not have written procedures for Quality Control (QC) Operations.
 
We have reviewed your response, dated April 3, 2017. In your response, you state that you have completed the correction for this issue and provided within the new MMRs for the (b)(4) Antibiotc and (b)(4) Capsules (b)(4) products written specifications for each point, step, or stage within the manufacturing process where control is necessary (provided in Attachments 5 and 6). However based on the documentation you provided, your response is inadequate in that you fail to provide a written procedure that explains the responsibilities of the QC unit. You must first establish written procedures for your quality control unit before you can implement quality control into your operations. For example, you have included signature blocks within the new MMRs which indicate the review and approval by the QC unit; however, this corrective action is not a written procedure which explains the responsibilities of your quality unit.
 
5)    You failed to establish written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Further, you did not make and keep written procedures for the review and investigation of products, as required by 21 CFR 111.570(b). Specifically, during the inspection our investigator observed you do not have written complaint procedures, nor do you keep records of complaints.
 
6)    Your batch production record (BPR) did not include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260. For example, your batch production record for (b)(4) did not include the following:
  • The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
  • The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment longs, where this information is retained [21 CFR 111.260(c)];
  • Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g) [21 CFR 111.260(i)];
  • Documentation of the manufacture of the batch at the time of performance, as required by 21 CFR 111.260(j). Specifically, the following information was not documented in your BPRs at the time of performance.
  • The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)];
  • The initials of the person responsible for verifying the addition of component to the batch [21 CFR 111.260(j)(2)(iv)];
  • Documentation, at the time of performance, of packaging and labeling operations, as required by 21 CFR 111.260(k), including (1) the unique identifier that you assigned to packaging and labels used [ 21 CFR 111.260(k)(1)];
  • Documentation at the time of performance that quality control reviewed the BPR, including any monitoring operation and the results of any tests and examinations on the finished batches of dietary supplements, and approved and released the batch and the packaged and labeled dietary supplements [ 21 CFR 111.260(l)].
Dietary Supplement Misbranding Violations
 
Further, even if the labeling for the (b)(4) and (b)(4) Antibiotc products did not make therapeutic claims, which make the products unapproved new drugs, these products would be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. Specifically during the inspection of your facility, our investigator collected labels associated with many of the products you manufacture. Our review of the product labels revealed that the products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as follows:  
 
1)    The (b)(4) Capsules (b)(4), and (b)(4) products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fail to identify the product by using the term “dietary supplement” as a part of the product’s statement of identity, as required by 21 CFR 101.3(g).
 
2)    The (b)(4) Formula, (b)(4) B-Complex, and (b)(4) Capsules (b)(4) products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example,
  • The (b)(4) Formula product label lists %DV for dietary ingredients for which FDA has not established Daily Values. For example, the product label lists a DV for glucosamine sulfate not in accordance 21 CFR 101.36(b)(3)(iv).
  • The (b)(4) Capsules (b)(4) product, “Supplement Facts” title must be set in a type size larger than all other print size in the nutrition label and must be set the full width of the nutrition label; the nutrition information must be enclosed in a box by using hairlines; and a heavy bar shall be placed as required by 101.36(e). Furthermore, dietary fiber must be indented in accordance with 21 CFR 101.36(b)(2)(i)(B) and 101.9(c)(6)(i).
  • The (b)(4) B-Complex declares vitamin B3 and vitamin B5 which is not the nomenclature or synonym specified for niacin and pantothenic acid in 21 CFR 101.9 or 101.36(b)(2)(i)(B). Further, the product label lists %DV for biotin and iodine in the incorrect increment. The percent of Daily Value must be expressed to the nearest whole percent [21 CFR 101.36(b)(2)(iii)(C)].
  • The (b)(4) B-Complex declares product label lists pantothenic acid in the wrong order. Pantothenic acid, its quantitative amount by weight per serving, and percent of the daily value should be listed after biotin and before iodine in accordance with 21 CFR 101.36(b)(2)(i)(B).
3)    The (b)(4) and (b)(4) Capsules (b)(4) products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplements. “Domestic address or domestic phone number” means a complete address or phone number.
 
4)    The (b)(4) Capsules (b)(4) and (b)(4) products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] in that the serving size declared on the labels are either not expressed in a common household measure that expresses the serving size of the food or is incorrect. For example,
  • The (b)(4) Capsules (b)(4) product label’s serving size is not declared in a common household measure that is appropriate to the product. Specifically, the product label does not declare the serving size using a term that is appropriate for the form of the product, such as “capsule,” in accordance with 21 CFR 101.36(b)(1)(i).
  • The (b)(4) product label’s serving size is 2 tablets, but the suggested use is stated as 2 to 4 tablets. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2.
5)    The (b)(4) Capsules (b)(4) and (b)(4) B-Complex products are misbranded within the meaning of sections 403(s)(2)(A) and 403(q)(5)(F) of the 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,
  • The (b)(4) Capsules (b)(4) label suggests that the product contains fenugreek, (b)(4), and (b)(4). However, these dietary ingredients and their quantitative amounts by weight per serving are not listed in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(3).
  • The (b)(4) B-Complex label contains ingredient information to suggest that the product contains calcium, phosphorus, iron, potassium, sodium, and magnesium in a proprietary blend. However, these (b)(2)-dietary ingredients and their quantitative amount by weight per serving are not listed in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(2) and 101.36(c)(1).
6)    The (b)(4) Capsules (b)(4) product is misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the label fails to declare the number of servings per container, in accordance with 21 CFR 101.36(b)(1)(ii).
 
7)    The (b)(4) Capsules (b)(4) and (b)(4) Formula products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that they fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
8)    The (b)(4) Formula, and (b)(4) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the 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. For example,
  • The (b)(4) B-Complex label declares the dietary ingredient PABA, but this is not the common or usual name for the dietary ingredient.
  • The (b)(4) Formula label declares the dietary ingredient Proanthocyanidins (OPC) but this is not the common or usual name for the dietary ingredient.
  • The (b)(4) label declares the ingredient “vegetable stearine” but does not specify the name of the vegetable and declares “magnesium salt” but does not specify the salt component.
9)    The (b)(4) product is misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the nutrition information provided in the Supplement Facts panel fails to declare the vitamins and minerals about which a claim has been made in accordance with 21 CFR 101.36(b)(2)(i). Specifically, the (b)(4) product label makes a claim “contains: …minerals, …B5, B12, and iron”, but the applicable dietary ingredients are not declared in the Supplement Facts panel and therefore, fail to meet the requirements of 21 CFR 101.36(b)(2)(i). Furthermore, we note that the use of the term “contains” is construed as a “good source” nutrient content claim according to 21 CFR 101.54(c). In accordance with 21 CFR 101.54(c), the terms “good source” or “contains” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 10 to 19 percent of the Reference Daily Intake (RDI) or Daily value (DV) per reference amount customarily consumed (RACC). Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(l)(A) of the Act.
 
10)    The (b)(4) Capsules (b)(4), (b)(4) Formula, and (b)(4) B-Complex products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail 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).
 
This letter is not an intended to be an all-inclusive list of violations in connection with the products you manufacture. It is your responsibility to ensure that your establishment and products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
 
In addition we note that insofar the products are intended to be marketed as dietary supplements, we also offer the following comments:
  • The (b)(4) Capsules (b)(4) product label does not bear the following statement: “Percent Daily Values are based on a 2,000 calorie diet.” We note this statement is required when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein [21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)].
  • The (b)(4) and (b)(4) B-Complex products’ information panels includes nutrition or ingredient information intermingled with information that is considered intervening material. Examples of intervening material are the statements of “(b)(4),” “non-GMO,” the product bar code, “(b)(4) ingredients...” statement, honey warning, and “(b)(4)” [21 CFR 101.2(e)].
  • The (b)(4) Capsules (b)(4) product label implies that (b)(4) mg is the net contents for (b)(4) Vegetarian Capsules. We suggest changing the (b)(4) mg to reflect that this quantity is for one capsule.
  • The (b)(4) B-Complex product label declares the net weight in grams, but the net weight must also be declared in avoirdupois pound and ounce in accordance with 21 CFR 101.105(b)(1).
  • The (b)(4) product label’s ingredients statement lists vegetable cellulose and also cellulose implying that there are two different types of cellulose.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, the FDA may assess fees to cover any reinspection-related costs.
 
If you have any questions regarding this letter, please contact Hanna L. Potter, Compliance Officer, at 303-236-3094. Please reference “CMS number 522767” in your response.
 
Your written reply should be sent to:
 
Hanna L. Potter
Compliance Officer
U.S. Food and Drug Administration
P.O. Box 25087
Denver, CO 80225-0087
 
Sincerely,
/S/
LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Food Operations – Division IV West
 
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