Aurobindo Pharma’s Andhra plant gets 1 observation from USFDA following inspection

21 Sep 2023 , 09:20 AM

Aurobindo Pharma said on Wednesday that the US Food and Drug Administration issued a Form 483 with one observation after evaluating its formulation production facility in Andhra Pradesh.

The US Food and Drug Administration (US FDA) inspected APL Healthcare Ltd, a wholly-owned subsidiary of the pharma company, in the Tirupati district of Andhra Pradesh from September 13 to 19, 2023, according to a regulatory filing by the Hyderabad-based drug major.

It was mentioned that at the end of the inspection, a Form 483 was given with one procedural observation.

According to the USFDA, after the completion of an inspection, a Form 483 is sent to the firm’s management if the investigator observes any conditions that may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and other related Acts.

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