Repeat Quality Deviations Found at India Facility

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FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

FDA sent a warning letter, dated August 9, 2018, to Apotex Research Private Limited detailing violations of current good manufacturing practices (CGMP) at the company’s Bangalore, India facility. The violations, which included failure to investigate batch failures, were observed during an FDA inspection conducted from November 6­­–17, 2017.

Specifically, inspectors found the company had failed to thoroughly investigate batch discrepancies and failures and in-process specifications were not established. According to FDA, the company’s quality systems are “inadequate”, and its quality unity does not have appropriate authority.

The warning letter stated that FDA placed the company on Import Alert 66-40 on April 12, 2018. The violations found were similar to previous ones found at other Apotex facilities, according to FDA, and other facilities were placed on Import Alert in 2014.

“FDA has previously communicated about the need for appropriate and global quality oversight to Apotex senior management during several regulatory meetings. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” the letter stated.


The agency recommended the company use a qualified consultant to assist with fixing the violations. “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the agency stated.

Source: FDA