Cosmetic Manufacturers Pty Ltd. - 719225 - 02/06/2026

Why It Matters

The violations halt the company’s U.S. drug supply, threatening revenue and eroding trust with contract partners. Compliance lapses also signal broader risks for multinational contract manufacturers navigating FDA regulations.

Key Takeaways

• FDA cited multiple CGMP violations at Cosmetic Manufacturers
• Import Alert 66‑40 blocks U.S. entry of their products
• Company must halt U.S. drug production pending remediation
• 15‑day response deadline for detailed corrective action plan
• Non‑compliance risks market access and future approvals

Pulse Analysis

The FDA’s warning letter underscores the agency’s rigorous enforcement of CGMP standards for finished pharmaceuticals, especially for foreign contract manufacturers seeking entry into the U.S. market. By invoking Import Alert 66‑40, the FDA signals that any product lacking documented compliance will be denied admission at the border, a move that protects public health but can swiftly disrupt global supply chains. For Cosmetic Manufacturers, the cited deficiencies—ranging from inadequate batch‑release testing to insufficient equipment qualification—represent fundamental gaps that the regulator deems unacceptable.

Operationally, the immediate cessation of U.S. drug production forces the company to reassess its contract manufacturing model. Clients relying on Australian‑sourced APIs or finished dosage forms must seek alternative suppliers, potentially incurring higher costs and lead‑time delays. The 15‑day response window compels the firm to develop a comprehensive remediation plan, including laboratory re‑validation, updated specifications, and a robust cleaning‑validation program. Financial exposure extends beyond lost sales; the firm may also face recall expenses, legal liabilities, and damage to its reputation within the highly regulated pharmaceutical ecosystem.

Strategically, this episode highlights the critical importance of proactive compliance infrastructure for any entity engaged in cross‑border drug manufacturing. Implementing continuous process verification, routine environmental monitoring, and a transparent change‑management system can mitigate the risk of future FDA actions. Companies should also cultivate strong quality agreements with contract partners, ensuring that responsibility for CGMP adherence is clearly delineated. By addressing the FDA’s findings swiftly and thoroughly, Cosmetic Manufacturers can restore market access and reinforce confidence among regulators and customers alike.

Cosmetic Manufacturers Pty Ltd. - 719225 - 02/06/2026

February 6, 2026

To:

Mr. Valentine P. Fittler

CEO & Managing Director

Cosmetic Manufacturers Pty Ltd.

14 Kingston Drive, Helensvale, Queensland, Australia

Dear Mr. Fittler,

The United States Food and Drug Administration (FDA) inspected your drug‑manufacturing facility, Cosmetic Manufacturers (Aust) Pty Ltd., FEI 3007187387, from 31 March to 8 April 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (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).

We reviewed your 23 April 2025 response to our Form FDA 483 and acknowledge receipt of your subsequent correspondence.

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

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1. Failure to perform appropriate laboratory determination of satisfactory conformance to final specifications for each batch (21 CFR 211.165(a))

You did not ensure drug products were evaluated for all critical quality attributes. You did not test drug products for identity, strength of the active ingredient, particulate and foreign matter, or preservative content.

In response, provide:

• A comprehensive assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies, together with a detailed remediation plan and effectiveness‑evaluation strategy.

• An updated list of chemical and microbial specifications, including test methods, used to analyze each batch before disposition. Include a description of how you will ensure U.S.‑bound products meet suitable batch‑release criteria, with references to qualified consultants and USP sources.

• Scientific justification for each chemical and microbial specification.

• An action plan and timeline for full chemical and microbiological testing of reserve samples of all U.S.‑distributed batches that are within expiry as of the date of this letter.

• A summary of results from testing reserve samples, and, if substandard products are identified, rapid corrective actions such as customer notification and product recalls.

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2. Failure to establish laboratory controls with scientifically sound specifications, standards, sampling plans, and test procedures (21 CFR 211.160(b))

Your testing and specifications for components used in your products are inadequate. You did not test samples for all significant quality attributes, nor have you established the suitability of test methods, including evaluation of potential microbiological growth inhibition during bioburden testing.

In response, provide:

• A comprehensive assessment of all component and product specifications and limits associated with U.S. drug manufacture, identifying and correcting those that do not align with U.S. requirements.

• A procedure for monitoring your system that specifies routine microbial testing to ensure acceptability for each batch.

• Current action/alert limits for total counts and objectionable organisms used for your system.

• A procedure governing ongoing control and monitoring to ensure the system consistently meets USP monograph specifications and appropriate microbial limits.

• The protocol, sampling method(s), and test method(s) used to assess potential growth inhibition of U.S.‑distributed drug products.

• The protocol and report supporting the detectability of Burkholderia cepacia using your existing test method for detection of Pseudomonads.

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3. Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a))

Your manufacturing process validation for bulk solutions was inadequate. Sampling methodologies lacked scientific justification, and you did not test for the concentration of the active ingredient in each product. The validation report failed to meet the pre‑established coefficient‑of‑variation criterion.

In response, provide:

• A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, including procedures for process performance qualification and ongoing monitoring of intra‑batch and inter‑batch variation.

• A timeline for performing appropriate process performance qualification for each marketed drug product, together with a risk assessment and follow‑up actions for products distributed without prior validation.

• Process performance protocols and written procedures for equipment and facility qualification, including explanations for each control parameter and acceptance criterion.

• A detailed program for designing, validating, maintaining, controlling, and monitoring each manufacturing process, with vigilant monitoring of intra‑batch and inter‑batch variation.

• An independent assessment of your environmental monitoring program, including limits, sampling locations and frequencies, deviation investigations, trend analysis, and a comprehensive CAPA plan.

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4. Failure to use equipment of appropriate design, size, and location (21 CFR 211.63)

You have not demonstrated that all equipment used to manufacture finished drug products is suitable for its intended use. Qualification documentation for the filler machine lacks scientific justification, and cleaning validation does not demonstrate reproducibility or adequate justification for equipment choices.

In response, provide:

• A plan for ensuring each piece of equipment is appropriately qualified for its purpose, with detailed explanations for each use.

• Improvements to your cleaning validation program, emphasizing worst‑case conditions (high‑toxicity drugs, high‑potency drugs, low‑solubility drugs, residues difficult to clean, challenging swabbing locations, maximum hold times).

• Steps required in your change‑management system before introducing new manufacturing equipment or products, including a summary of updated SOPs for verification and validation of cleaning procedures.

• The date by which your cleaning processes for drug‑manufacturing equipment will be validated.

• Interim controls to ensure equipment is suitably clean.

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Responsibilities as a Contractor

Contractors are extensions of the manufacturer. You are responsible for the quality of drugs produced as a contract facility, regardless of any quality agreement with product owners. See FDA’s guidance “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (https://www.fda.gov/regulatory‑information/search‑fda‑guidance‑documents/contract‑manufacturing‑arrangements‑drugs‑quality‑agreements‑guidance‑industry).

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Drug Production Ceased

We acknowledge your commitment to cease production of all drugs at this facility for the U.S. market. If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming. Provide a summary of your remediations to demonstrate completion of corrective‑action and preventive‑action (CAPA) activities.

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Conclusion

The violations cited are not an all‑inclusive list. You must investigate, determine causes, and prevent recurrence. FDA has placed all drugs and drug products offered for import from your firm on Import Alert 66‑40 (January 8 2026). Promptly correct any violations. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until all violations are addressed and CGMP compliance is confirmed. Re‑inspection may be conducted to verify corrective actions.

Failure to address violations may result in continued refusal of admission of articles manufactured at Cosmetic Manufacturers (Aust) Pty Ltd. into the United States under section 801(a)(3) of the FD&C Act.

This letter notifies you of our findings and provides an opportunity to address the deficiencies. Respond in writing within 15 working days, specifying actions taken to address each violation and prevent recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and provide a schedule for completion.

Send your electronic reply to CDER‑OC‑OMQ‑[email protected], identifying your response with FEI 3007187387 and ATTN: Jason F. Chancey.

Sincerely,

/S/

Francis Godwin

Director, Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research (CDER)