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Pharmaceuticals / Inspections and Audits

FDA Cites California Drugmaker for Testing

March 18, 2019
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The FDA cited drug manufacturer Gordon Laboratories for testing and other violations at its Carson, California facility.

During a Nov. 6-19, 2018, inspection, the agency noted that the firm’s written stability program lacked dependable test methods. The analytical method used to determine stability was not suited for the task, and the stability data used in support of product expiration dates did not identify degradation products or show the impact of oxidation and light on the drug products, the agency said.

The facility’s electronic records didn’t meet retention requirements to ensure their trustworthiness and equivalence to paper records. Staff had the ability to delete high-performance liquid chromatography data and spectroscopy data from local instruments where the data was saved.

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