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FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.
FDA sent a warning letter, dated Aug. 2, 2019, to Emcure Pharmaceuticals after an inspection of the company’s Maharashtra, India facility found that the company had failed to thoroughly test sterility failures. The inspection occurred from Feb. 11–20, 2019.
The letter stated the company did not adequately investigate sterility failures that occurred during routine batch testing. The company’s determination that the cause was laboratory error was inadequate and lacked sufficient data, according to FDA. “Your firm’s investigations substantially addressed the potential for microbial contamination during sterility testing, but deemphasized potential manufacturing causes,” the letter stated. The agency is requesting the company perform an assessment of its system for investigations, have a third-party evaluate the company’s records and sterilizer, and send FDA plans and procedures for handling future sterility failures.
According to FDA, the sterility issues found at the company were repeat violations from a previous inspection that was performed Aug. 7–17, 2017. “You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations,” the agency stated in the letter.