Drug Approval

Dr. Reddy's Laboratories updates on PAI of formulations facility

The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.

Dr. Reddy’s Laboratories Limited has informed that the United States Food & Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh.

The inspection was conducted from 30th June, 2022 to 7th July, 2022 and the company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.

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