Two FDA warning letters to manufacturers of creams

Recommendation

7-9 March 2023

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The U.S. Food and Drug Administration recently issued warning letters to two cream manufacturers (a contract manufacturers based in Australia and a Korea-based drugmaker).

In its warning letter to the Korea-based drugmaker, the FDA cites the company for two GMP violations observed during a four-day inspection in  September 2017:

• The manufacturer failed to investigate out-of-specification (OOS) results for certain lots of an over-the-counter (OTC) cream and instead retested and invalidated the OOS results without justification.
• The company failed to follow its own written procedures for document control, which require quality control unit approval for discarding records. The investigator observed documents and records, including batch production records, certificates of analysis, and laboratory worksheets, that were torn and discarded without documented quality unit approval.

The following GMP Issues were found during a three-day inspection in December 2017 at the Australian contract manufacturer site:

• Creams were released without testing the identity and strength of the active ingredients.
• Incoming active pharmaceutical ingredients (APIs) and other components used in cream manufacturing have not been tested to ensure that each component met specifications. Instead, the manufacturer relied on suppliers’ certificates of analysis (CoA).
• The cream manufacturing process was not validated and no equipment qualification for the filling machine has been conducted.
• The expiration date was based on stability test data from the customer’s previous contract manufacturer. The formulation remained the same, but the manufacturing site, equipment, raw materials, and container-closures are different. Furthermore, the stability study conducted by the previous contract manufacturer contained out-of-specification (OOS) results including sub-potent content and low viscosity. 

Please see two FDA warning letters issued to Kolmar Korea Co. Ltd. and Jalco Cosmetics Pty Ltd..