FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Australian Manufacturer Nailed for Process Validation and Testing Shortcomings

June 5, 2018
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The FDA hit Australian OTC drugmaker Jalco Cosmetics with a warning letter in a follow-up to a December inspection that revealed process validation and testing deficiencies at its facility in Silverwater, New South Wales.

The inspector found that the firm did not test the identity and strength of active ingredients used in a cream product and failed to test all batches for finished product attributes before release.

In addition, the facility did not test to ensure that all incoming APIs and other components used in manufacturing its cream product met specifications, accepting suppliers’ certificates of analysis for the identity of each incoming material without doing its own testing.

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