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Medgel Private Limited, a drug manufacturer in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter capsule products. During a January 2023 inspection, the FDA identified that the company failed to adequately investigate out-of-specification (OOS) test results, particularly by invalidating results without sufficient scientific justification and attributing failures to sample preparation errors without proper hypothesis testing or evidence. The firm subsequently retested and released batches after obtaining passing results, rendering the drug products adulterated under federal law.