The United States Food and Drug Administration (FDA) issues a warning letter to Cosmetic Manufacturers Pty Ltd. of Queensland, Australia for violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

The FDA inspected the drug manufacturing facility from March 31 to April 8, 2025. In a letter dated Fab. 6, 2026, it said:

“The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cosmetic Manufacturers (Aust) Pty Ltd., FEI 3007187387, at 14 Kingston Drive, Helensvale, Queensland, from March 31 to April 8, 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).

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

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

“1. 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)).

“2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

“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 (21 CFR 211.100(a)).

“4. Your firm failed to use equipment in the manufacture, processing, packing or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).”

Production Ceased

“We acknowledge your commitment to cease production of all drugs at this facility for the US market.

“If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA),” said the letter.

FDA placed all drugs and drug products offered for import into the United States from this firm on Import Alert 66-40 on Jan. 8, 2026.

The letter continued: “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.”

The full letter can be viewed here.