Divi’s Labs Receives FDA Warning Letter for Indian API Mfg Plant

Divi’s Laboratories has received a Warning Letter from the US Food and Drug Administration (FDA) for its active pharmaceutical ingredient (API) manufacturing facility in Visakhapatnam District, India based on an inspection of the facility from November 29 to December 6, 2016. The FDA has reviewed the company’s December 24, 2016, response in detail and has acknowledged receipt of subsequent correspondence. The agency also documented that Divi’s Labs limited and/or refused an FDA inspection, prompting the agency to consider the company’s drugs adulterated under the Food Drug & Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act, in that the drugs have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and/or refused inspection.

During its inspection, the FDA observed several deviations including, but not limited to, a failure to ensure that test procedures are scientifically sound to ensure compliance with established quality/purity standards for APIs; failure to prevent unauthorized access or changes to data and failure to provide adequate controls to prevent manipulation and omission of data; and limiting access to, or copying of, records.

In response the letter, the FDA requires Divi’s Labs to provide updated analyses of all lots within expiry that take into account any changes to specific test methods and chromatographic parameters; a comprehensive investigation into the extent of inaccuracies in data records and reporting; a current risk assessment of the potential effects of the observed failures on the quality of drugs that includes analyses of risks to patients and risks posed by ongoing operations. Divi’s Labs is also to provide a management strategy that includes details of the company’s global corrective action and preventive action plan.

Source: Food and Drug Administration

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