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Pharmaceuticals / Inspections and Audits

Indian Drugmaker Draws FDA Warning for Adulterated Products

Aug. 16, 2018

The FDA sent a warning letter to Apotex Research after discovering significant and repeat violations at its Bangalore facility that led to adulterated finished drug products.

The agency found that the firm’s investigations of out-of-specification lab results and manufacturing deviations were inadequate and lacked conclusions supported by scientific evidence.

For example, when the firm investigated OOS and out-of-trend assay results for certain tablets, it concluded the results were due to an analyst’s error during sampling preparation but didn’t provide any evidence to support its findings.

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