FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

California Contract Manufacturer Warned Over CGMP Violations

Dec. 4, 2018

Los Angeles, California OTC drugmaker Product Packaging West drew a warning letter from the FDA for current good manufacturing practice violations observed at its facility, including inadequate recordkeeping and component testing.

The agency inspection, conducted from March 7 to 13, brought to light multiple problems at the facility. For example, the firm failed to test incoming components for identity, purity, quality and strength, and failed to check the reliability of its suppliers’ certificates of analysis.

The facility “failed to perform identification testing for all incoming glycerin lots to verify identity and determine whether diethylene glycol or ethylene glycol was present,” the agency said. Because of this, the firm could not ensure the component lots were acceptable for use in drug manufacturing.

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