Indian Drugmaker Draws FDA Warning for Adulterated Products
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.
The testing associated with the investigation “did not demonstrate that sample preparation caused the aberrant results as assay values did not differ substantially when you varied sample preparation,” the agency said.
Another observation focused on in-process specifications. The facility’s management declined to perform a certain test on the grounds that the material involved could fail assay specifications.
Regulators ordered the firm to overhaul its procedures to ensure materials are tested for appropriate quality attributes and provide updates on the procedural changes.
The inspection also revealed that the firm’s quality unit failed to fully exercise its authority to make sure all investigations identified root causes.
The FDA placed Apotex Research on an import alert for automatic detention of its finished drug products at U.S. ports on April 12, 2018.
The agency cited similar violations and deviations at the company’s facilities in the last five years. The Bangalore facility was previously placed on an import alert in September 2014 and received a warning letter in January 2015.