Medical Chemical Corporation - 706007 - 07/09/2025

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Warning Letter 320-25-91

July 9, 2025

Dear Mr. Didier:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medical Chemical Corporation, FEI 2013736, at 19430 Van Ness Avenue, Torrance, from February 12 to 18, 2025.

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, “MED CHEM Tincture Green Soap” drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such product into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Furthermore, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that your drug products, Tincture Green, NDC 12745-041, and Isopropyl Alcohol, NDC 12745-105, are not properly listed as required by section 510(j) of the FD&C Act.

Your firm has not fulfilled its listing obligations under 510(j) of the FD&C Act and 21 CFR 207, which is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). 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). These violations are described in more detail below.

CGMP Violations

We reviewed your February 28, 2025 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.

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

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) topical drug products, including hand sanitizers, Tincture Green Soap USP, and Isopropyl Alcohol 70% v/v. You failed to adequately perform identity testing on each shipment of each lot of incoming components (e.g., ethanol, glycerin) used in the manufacture of your OTC topical drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Products Containing Ethyl Alcohol and Isopropyl Alcohol

You failed to adequately test your incoming component ethyl alcohol (ethanol), used as an active pharmaceutical ingredient (API), for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download.

Furthermore, you failed to demonstrate that the component alcohol (“C40B (b)(4) PROOF SDA 40B ETHYL ALCOHOL BULK”), used to manufacture your drug product Tincture Green Soap USP, meets United States Pharmacopoeia (USP) monograph specifications. For example, we reviewed your raw material specification for your component alcohol and note that the specifications failed to demonstrate performance of the USP monograph identification parts A, B, and C.

Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination

You also failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity, prior to use in manufacturing your OTC topical drug products.

Identity testing for glycerin and certain other high-risk drug components includes a limit test in the USP to ensure the component meets the relevant safety limits for DEG or EG levels. 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 the 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 high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

In your response, you state that you perform identity testing, use raw materials certified by trusted suppliers, and have added or will add certain assays to your specifications. Your response is inadequate because you do not provide adequate details to demonstrate identity testing meets all compendial requirements. Furthermore, your response does not address testing your high-risk drug components for DEG or EG contamination, or test ethanol for the presence of methanol contamination. Also, you do not address the potential impact on drug products in the U.S. market within expiry.

Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before use in production to ensure acceptable quality parameters are met.

In response to this letter, provide:

• 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.
• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
• 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 re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of alcohol, isopropyl alcohol, glycerin, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.
• 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 (SOP) that describes this COA validation program.
• A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
• A commitment to provide methanol test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of components within expiry of manufactured 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 methanol.
• 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 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 actions and preventive actions (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.

2. 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)).

You used “(b)(4) water” as a component to manufacture your OTC topical drug products. However, you have not established that the water system is adequately designed, maintained, and monitored to ensure that it consistently produces water suitable for its intended use. You lacked water system validation and failed to conduct total organic carbon (TOC) testing to ensure that your component water met (b)(4) Water United States Pharmacopeia (USP) monograph specifications.

Additionally, you obtained excessive microbial growth from the point of use, “(b)(4) (No hose)” location, following (b)(4) water system maintenance sanitization cycles. The inadequate control of your water system poses a potential risk for objectionable microbiological contamination into your drug products.

In your response, you state that you will “revalidate” your (b)(4) water system and include TOC testing in your water specification. Your response is inadequate because you do not provide your initial water system validation, nor do you provide adequate details regarding your plan for performing water system validation, maintenance, and testing of the water system. Furthermore, you do not provide a timeline for the validation of your methods, nor do you consider retrospective testing of retained finished drug products that used water.

(b)(4) water for pharmaceutical use 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.

Furthermore, test methods must be validated to show they are suitable for their intended use, and equivalent or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications for microbial attributes. The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product must be established.

In response to this letter, provide:

• A (b)(4) water system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.
• 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.
• 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. Total microbial count limits for (b)(4) water systems are generally tighter than your proposed action limits for the topical liquid dosage forms produced by your firm.
• A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the system consistently produces water that meets (b)(4) Water, USP monograph specifications and appropriate microbial limits.
• Validation of your microbiological test methods, including growth promotion testing, demonstrating they are equivalent to, or better than USP compendial methods, and suitable for their intended use.

3. 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 quality unit (QU) failed to perform adequate oversight for the manufacture and testing of your OTC topical drug products. For example, your QU failed to ensure the following:

• Establishment and review of adequate batch production and control records for each batch of drug product which include complete information regarding each significant step in the manufacture, processing, packing, or holding of the batch (21 CFR 211.188(b)).
• Establishment and review of adequate laboratory records which include all data obtained during testing (21 CFR 211.194(a)).

In your response, you state that you have added the mixing time to the batch record, and you maintain a temperature log of your incubator. Your response is inadequate because you do not provide sufficient details to demonstrate your QU will ensure the establishment and review of manufacturing records.

Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and reproducible. Additionally, complete manufacturing records are necessary to reliably conduct batch record review, adequately investigate deviations and batch failures, and to ensure a continued state of validation processes.

An adequate QU overseeing all CGMP operations is necessary to ensure consistent 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 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 list of chemical and microbial test methods and specifications used to analyze each of your drug product before making a disposition decision, and the associated written procedures.

Unapproved New Drug and Misbranded Drug Violations

“MED CHEM Tincture Green Soap” 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.

Examples of claims observed on the “MED CHEM Tincture Green Soap” product labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:

  “Drug Facts Active Ingredients Ethyl Alcohol, 30% Purpose Antiseptic Uses Intended for . . . mild antisepsis of skin . . . Directions Mix with water. Lather and rinse” [from the product label]

Based on the above labeling claims, “MED CHEM Tincture Green Soap” is intended for use as a topical antiseptic drug product. This topical antiseptic product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your “MED CHEM Tincture Green Soap” drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

Over-the-Counter (OTC) topical and oral antiseptic drug products have been the subject of rulemakings under the Agency’s OTC Drug Review. In particular, consumer topical antiseptics were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use”, Proposed Rule, 78 FR 76444 (December 17, 2013) (Consumer Antiseptic Washes Proposed Rule). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) were classified as Category III for use in consumer antiseptic wash products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic wash.

Section 505G of the FD&C Act governs nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330—and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.

However, “MED CHEM Tincture Green Soap” does not conform to the 1994 TFM, as further amended by the Consumer Antiseptic Washes Proposed Rule, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505. The “MED CHEM Tincture Green Soap” product labeling states that its active ingredient is “Ethyl Alcohol, 30%” and provides the following directions for use: “Mix with water. Lather and rinse.” Your “MED CHEM Tincture Green Soap” product does not conform to the 1994 TFM as further amended or any other TFM or proposed or final rule. As noted above, ethyl alcohol is not one of the three active ingredients classified as Category III for use in consumer antiseptic wash products.¹ 

Accordingly, your product does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Additionally, “MED CHEM Tincture Green Soap” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce violations section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Drug Listing Violations

Section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 outline the requirements for establishment registration and listing of drug products. Under 21 CFR 207.57(b), registrants are required to update drug listing information twice each year, in June and December. Under 21 CFR 207.57(b)(2) registrants may satisfy the listing update requirement with respect to unchanged listing information by making a single “no changes” certification during the October 1st through December 31st annual registration period. If the drug listing data is not updated or certified, the outdated listing data will get inactivated at the next scheduled FDA inactivation period.² Your products, Tincture Green, NDC 12745-041, and Isopropyl Alcohol, NDC 12745-105, were not certified as required, thus they were inactivated by FDA in January 2024.

Therefore, your products Tincture Green and Isopropyl Alcohol are not properly listed under section 510(j) of the FD&C Act, rendering these drugs to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). 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). In addition, failure to provide listing information in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).

Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing, electronic health records, insurance reimbursement, and patient education.

We note that several of your firm’s drug listings are inactivated/uncertified. Firms must discontinue listed products when manufacturing and commercial distribution cease by adding an end marketing date which corresponds to the expiration date of the last lot in commercial distribution. It is your responsibility to ensure that all products manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions.

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. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. 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 address any violations.

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 2013736 and ATTN: Sena G. Dissmeyer.

Sincerely,
/S/

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

/S/

Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research

_________________________

1 We note that “tincture of green soap” was not evaluated as part of the consumer antiseptic wash rulemaking and was not one of the three active ingredients classified as Category III for use in consumer antiseptic wash products. On June 19, 2008, FDA issued a proposed rule that would determine that there were inadequate data to establish general recognition of safety and effectiveness for tincture of green soap for use as the active ingredient in a nonantimicrobial skin wound cleanser product. “Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients,” Proposed Rule, 73 FR 34895, 34901 (June 19, 2008).

2 See 84 FR 40417 (https://www.regulations.gov/document/FDA-2019-N-2374-0001).