Drugs

CGMP Issues at Australia’s Cosmetic Manufacturers Pty

A 3/31-4/8/2025 FDA inspection at the Cosmetic Manufacturers ' drug manufacturing facility in Helensvale, Queensland, Australia, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/6 Warning Letter says the specific violations were:

failure to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failure 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;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failure 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.

In the letter, FDA reminds the firm of its responsibility as a contractor for the quality of the drugs it produces, regardless of agreements with product owners. It points out that FDA issued a redacted Warning Letter and that redacted drug products were placed on an Import Alert.

The agency acknowledges the firm’s commitment to cease production of all drugs at the facility for the U.S. market and says it must meet all regulatory requirements if it decides to resume production.

Cosmetic Manufacturers was told to correct all violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome