Catwalk Cosmetic Laboratories Pty Ltd.

Warning Letter 320-25-18

November 21, 2024 Dear Mr. Lavender:

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 25, 2024 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Catwalk Cosmetic Laboratories Pty Ltd., FEI 3014345294, at 105 Capricorn Drive, Capricorn Park, Muizenberg, Western Cape, 7945 South Africa.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).

Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:

Your firm manufactures OTC drug products including (b)(4) Cream. Based on the records and information provided, you did not demonstrate that you adequately tested the identity of your incoming components (i.e., (b)(4)) used in the manufacture of your drug products. In your response, you state that you only check whether the appearance of the incoming components matches the description on the supplier’s certificate of analysis and, if possible, you check the rancidity of the components based on odor.

(b)(4)

The records and information you provided do not demonstrate that you adequately test each shipment of each lot of (b)(4) for identity, a component at higher risk for (b)(4) and (b)(4) contamination. Your response states that you do not perform (b)(4) or (b)(4) limit testing on your incoming (b)(4) component. Identity testing for (b)(4) and certain other high-risk drug components1 include a (b)(4) 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 the manufacture of your drug products.

The use of ingredients contaminated with (b)(4) or (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. (b)(4).

Without adequate testing you do not have scientific evidence that your raw materials conform to appropriate specifications prior to use in the manufacture of your drug products.

2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Based on the records and information provided, you did not demonstrate that you adequately tested your finished drug products prior to release and distribution. For example, you stated that you only perform pH, viscosity, and “organoleptic comparison” testing.

Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.

3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Based on the records and information provided, you did not demonstrate that your drug products remain acceptable throughout their assigned shelf life. For example, you indicated that potency and assay testing are not part of your stability program.

Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.

4. Your firm failed to establish 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)).

The information provided did not demonstrate that your manufacturing processes are reproducible and controlled to yield a product of uniform character and quality. Specifically, you stated that your firm does not have process validation procedures or process validation studies.

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 includes intensive monitoring and testing of throughout each significant process stage to characterize intra-batch variation and evaluates batches to 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.

5. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU did not adequately exercise its authority in the approval or rejection of components in your Materials System.

Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may also not be conducting appropriate oversight regarding CGMP operations.

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.

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 if your firm intends to resume manufacturing drugs for the U.S. market. 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.

Based on information collected during the inspection and FDA import records, there appear to be discrepancies in the electronic import entry submissions for your drug products, specifically regarding the declaration of the correct manufacturer. Prior to distributing products intended for the United States, you should ensure that the firms shipping or importing your drug products, and the entry filers transmitting the electronic data to U.S. Customs and Border Protection and FDA, are declaring your firm as the manufacturer, as well as using your registration number and product listing number(s). If other firms are shipping your products they may be declared as the shipper; however, your firm needs to be declared as the manufacturer. See 21 CFR 1.74(a)(1).

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.

FDA placed your firm on Import Alert 66-40 on November 18, 2024.

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 Catwalk Cosmetic Laboratories Pty Ltd., at 105 Capricorn Drive, Capricorn Park, Muizenberg, Western Cape, 7945, South Africa, 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.

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 3014345294 and ATTN: Rory Geyer.