Compliance Management

FDA Issues Form 483 for Lupin's Goa Facility

May 01, 2017


The U.S. FDA delivered an inspection report to Indian generic drugmaker Lupin Limited following an inspection of its Goa, India, facility earlier this month, according to RAPS. FDA noted Lupin failed to "thoroughly review any unexplained discrepancy" of certain batches or components of its drugs, regardless of whether they had been distributed.

The Form 483 reportedly lists three observations made by investigators during an inspection on March 27–April 7, 2017, which comes after about a year after the company received nine observations from an earlier inspection of the facility, the article said.

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