An active pharmaceutical ingredient (API) plant of Dr. Reddy’s Laboratories here has been issued a Form 483 with five observations, after an inspection by the US Food and Drug Administration (USFDA). “The audit of our API manufacturing plant-2 at Bollaram, Hyderabad, by the USFDA has been completed today. We have been issued a Form 483 with five observations,” Dr. Reddy’s intimated the exchanges.
The company said it will address the observations made “comprehensively within the stipulated timeline”, but did not share details of the nature of the observations. Shares of Dr. Reddy’s closed 0.77% lower at ₹2,631.60 apiece.
A Form 483 is issued by the USFDA notifying the management of the company of objectionable conditions found during an inspection that may constitute violation of the laws.
