Dr Reddy's says US FDA has issued Form 483 for Srikakulam API plant
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The US Food and Drug Adminisatration (FDA) has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form483 detailing two observations.
Dr Reddy’s confirmed the inspection in a Bombay Stock Exchange (BSE) filing today, explaining that it is already addressing the observations.
The Srikakulam facility was one of three Dr Reddy’s sites issued with a US FDA warning letter in 2015, the others being its finished formulation plant in Duvvada - also in Andhra Pradesh – and its API factory in Tripuraram, Telangana.
The plant makes APIs for foreign export, including bromfenacna, celecoxib, ibuprofen, ketorolac tromethamine, naproxen, naproxen sodium, glimeprid, linagliptin, liraglutide, and nateglinide.