Pharmaceutical Compliance

FDA Warning Letter: Major CGMP, Aseptic Processing and Microbiological Contamination Violations

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FDA Warning Letter: Major CGMP, Aseptic Processing and Microbiological Contamination Violations This FDA Warning Letter highlights significant violations of Current Good Manufacturing Practice (CGMP) requirements identified during an FDA inspection of a manufacturer of sterile prescription and over-the-counter (OTC) drug products. FDA determined that the firm’s manufacturing methods, facilities, and controls for manufacturing, processing, packing, … Read more

FDA Warning Letter: Major CGMP, Stability, OOS and Storage Violations

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FDA Warning Letter: Major CGMP, Stability, OOS and Storage Violations The FDA warning letter issued highlights identifies significant Current Good Manufacturing Practice (CGMP) deficiencies observed during an FDA inspection conducted from March 31 to April 3, 2026, at the firm’s drug manufacturing facility in Chatsworth, California. The FDA warning letter states that the firm’s methods, … Read more