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WARNING LETTER

FirstCham Co., Ltd. MARCS-CMS 672903 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Mr. Sang-Hoi Kim
Recipient Title
President
FirstCham Co., Ltd.

87, Geumil-ro, 700beon-Gil
Samseong-Myeon
Eumseong-gun
Chungcheongbuk-do
27653
South Korea

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Secondary Issuing Offices

United States

Warning Letter 320-24-31

April 3, 2024

Dear Mr. Kim:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, FirstCham Co., Ltd., FEI 3010970108, at 87, Geumil-ro, 700beon-Gil, Samseong-Myeon, Eumseong-gun, Chungcheongbuk-do, from October 23 to 27, 2023.

This warning letter summarizes significant violations of the Current Good Manufacturing Practices (CGMP) regulations for finished pharmaceuticals. See Tile 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, the Soo’Ae Hand Sanitizing Wipes product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Introduction or delivery for introduction of such product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). This violation is described in more detail below.

We reviewed your November 21, 2023 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.

During our inspection, our investigator observed specific violations including, but not limited to, the following:

CGMP Violations

1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm manufactures over-the-counter (OTC) hand sanitizer drug products without adequate assurance of the quality of raw materials. For example, you did not adequately test incoming raw materials, including identity testing of each shipment of each component lot used in the manufacture of your OTC drug products (e.g., benzalkonium chloride, glycerin). You also stated that you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Glycerin

You failed to adequately test each shipment of each lot of glycerin for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. We note that glycerin is an ingredient used in your hand sanitizing wipe drug products. Identity testing for glycerin and certain other high-risk drug components1 include a DEG/EG limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in manufacture of your drug products.

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

In your response, you state that you would include identity testing for glycerin. Your response is inadequate. You failed to provide sufficient details regarding how you will ensure adequate identity testing for each lot of each shipment of glycerin. You also did not adequately address testing of other incoming raw materials, and how you will validate your suppliers’ COA at appropriate intervals. Further, you do not address potential impact to drug products distributed to the United States that are within expiry.

Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality.

In response to this letter, provide:

  • A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of your drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
  • A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
  • A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.
  • The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
  • A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
  • A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
  • A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.

2. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Your laboratory records do not include complete testing data to support the testing performed. For example, your records lack a statement of methods used for testing, a statement of the results of tests and how they compare to the established specifications, a record of all critical equipment used, and confirmation of compliance with testing conditions.

In your response, you state that you will revise your records to reference good documentation practices and perform out-of-specification (OOS) investigations for the two batches of Benzalkonium chloride-based hand sanitizing wipes that were released based on inaccurate data. Your response is inadequate because you did not consider a retrospective assessment of potential impact to your products distributed to the United States within expiry. While you state that you will update your procedures to reference good documentation practices, you did not provide a detailed plan to implement good documentation practices throughout your laboratory operations.

All CGMP-related data must be retained, including data obtained by contract testing laboratories, to enable appropriate assessments and decisions by the quality unit (QU) and customers, and demonstrate ongoing control.

In response to this letter, provide:

  • A comprehensive independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
  • A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.

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, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)).

Lack of Process Validation

You failed to provide data to demonstrate that you adequately validate your manufacturing processes used to manufacture your OTC drug products and demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality.

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 for industry, 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.

Inadequate Water System

Your firm uses water as a component to manufacture your OTC drug products. You failed to adequately design your water system to ensure it was suitable for producing water used in the formulation of your drug products (i.e., multiple dead-legs, non-circulating loop) and to provide documentation of its qualification. You also failed to show that your water system is monitored adequately to ensure it consistently produces water that meets appropriate microbial limits.

(b)(4) water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts and identity of contamination in the system is integral to ensuring oversight of ongoing state of control and suitability of water for use in manufacturing operations.

Your response regarding process validation and your water system is inadequate. You did not provide a detailed plan or supporting documentation for validating your drug production process or your water system. Further, you did not address the adequacy of your overall water system design to ensure your water meets quality attributes until the system consistently produces water meeting (b)(4) Water USP monograph specifications and appropriate microbial limits. You also failed to provide interim measures and assess the impact of using water from an unvalidated water system on the quality of drug products you manufacture.

In response to this letter, provide:

  • 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 (PPQ), 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.
  • Provide a detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
  • 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.
  • Timelines for completed PPQ for marketed drug products for which a state of control has not been adequately/fully established.
  • A comprehensive, independent assessment of your water system design, control, and maintenance.
  • A thorough remediation plan to install and operate a suitable water system. Include a robust ongoing control, maintenance, and monitoring program to ensure the remediated system design consistently produces water adhering to (b)(4) Water, USP monograph specifications, and appropriate microbial limits.
  • The current action/alert limits for total counts and objectionable organisms used for your (b)(4) Water system. Ensure that the total count limits for your (b)(4) water are appropriately stringent in view of the intended use of each of the products produced by your firm.
  • A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.

4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your QU did not provide adequate oversight for the manufacture of your OTC drug products. For example, you were unaware of numerous CGMP requirements and failed to establish written procedures including, but not limited to, process validation, equipment qualification, analytical method validation, cleaning validation, and supplier qualification. In addition, you approved an inadequate stability study and failed to ensure reliability of data relating to drug product quality (e.g., prefilled documents, deleted chromatographic data, inadequate investigations, etc.).

In your response, you briefly mention some corrective actions including validation, qualification, and good documentation practices. Your response is inadequate because you did not provide how you would assure adequate quality oversight. It also lacks detailed supportive documentation, a retrospective assessment evaluating impact to your drug products distributed to the Unites States that are within expiry, and your interim production plans are unclear.

Your firm’s quality systems are inadequate. An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. See FDA’s guidance document Quality Systems approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211 at https://www.fda.gov/media/71023/download.

In response to this letter, provide:

  • A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:

    o A determination of whether procedures used by your firm are robust and appropriate.
    o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
    o A complete and final review of each batch and its related information before the QU disposition decision.
    o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
    o Also describe how top management supports quality assurance and reliable operations, including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.

  • 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, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
  • A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
  • A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:

    o Stability indicating methods.
    o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
    o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.
    o Detailed definition of the specific attributes to be tested at each station (timepoint).

  • All procedures that describe these and other elements of your remediated stability program.

Misbranded Drug Violation

The Soo’Ae Hand Sanitizing Wipes product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a consumer topical antiseptic rub.

Examples of claims observed on the Soo’Ae Hand Sanitizing Wipes product label and labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:
First Cham Co., Ltd, Samseong-Myeon, Eumseong-gun, Chungcheongbuk-do FEI: 3010970108 page 8

“SOO’AE . . . HAND SANITIZING WIPES . . . Drug Facts . . . Purpose . . . Antiseptic handwash . . . Uses . . . For hand washing to decrease bacteria on the skin” [from your product label]

“Hand Sanitizing Wipes . . . Instant antibacterial hand sanitizing wipes with the alcohol-free formula for everyone and everywhere! . . . FDA REGISTERED” [from your product website at https://sooaenewyork.com/product/hand-sanitizing-wipes/]

Soo’Ae Hand Sanitizing Wipes drug product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product labeling misleadingly suggests that the drug product is approved or endorsed by FDA in some way. Specifically, the product website, www.sooaenewyork.com, which is listed on the product label includes the statement “Key benefits 1. FDA registered” and includes the acronym “FDA” in a form that is similar to the FDA logo, displayed above the word “REGISTERED” and above the term “FDA REGISTERED.” FDA’s regulations provide that “[r]egistration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed” (21 CFR 207.77(a)). However, the general public is not likely to be familiar with the details of FDA’s regulations. The assertion that your product is “FDA registered” combined with your use of the acronym “FDA” in a form that is similar to the FDA logo and that it is a key benefit on your product’s website misleadingly suggests that the drug product is approved or endorsed by FDA in some way. Your Soo’Ae Hand Sanitizing Wipes product is not the subject of an FDA-approved application. Therefore, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its labeling is false or misleading. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Additionally, we note that your Soo’Ae Hand Sanitizing Wipes product is marketed as a “hand sanitizer.” Hand sanitizers generally refer to consumer or health care antiseptic rubs. However, the label for your Soo’Ae Hand Sanitizing Wipes product also suggests that it can be used as a consumer or health care antiseptic wash. For instance, the label states that the product can be used “For hand washing to decrease bacteria on the skin” and as an “Antiseptic handwash.” A hand sanitizer wipe drug product marketed under section 505G of the FD&C Act cannot be both an antiseptic rub and an antiseptic wash as the directions for use conflict with each other and a wipe is not an acceptable dosage form for an antiseptic wash. A hand sanitizer wipe is considered an antiseptic rub product that is not intended to be rinsed off after use.2

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.

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 in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

FDA placed your firm on Import Alert 66-40 on March 25, 2024.

Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at First Cham Co., Ltd., at 87, Geumil-ro, 700beon-Gil, Samseong-Myeon, Eumseong-gun, Chungcheongbuk-do, into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).

Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at FirstCham Co., Ltd., at 87, Geumil-ro, 700beon-Gil, Samseong-Myeon, Eumseong-gun, Chungcheongbuk-do, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) and are misbranded under section 502 of the FD&C Act, respectively.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3010970108 and ATTN: Reba Gates.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA

_________________

1 Components with higher risk of DEG or EG contamination compared to other drug components.

2 Consumer Antiseptics Washes Proposed Rule (78 FR 76444 at 76447, December 17, 2013)

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