Dr Reddy’s Laboratories receives two observations for Andhra Pradesh facility

New Delhi: Drug major Dr Reddy’s Laboratories has received a Form 483 with two observations from the US Food and Drug Administration (USFDA) following an inspection at its manufacturing facility in Pydibhimavaram, Andhra Pradesh.

The US health regulator completed a Pre-Approval Inspection (PAI) at the company's FTO-11 manufacturing unit from October 5-7, Dr Reddy's Laboratories said in a regulatory filing on Thursday.

The USFDA Form 483 is issued at the conclusion of an inspection when investigators observe conditions that, in their judgment, may violate regulatory standards.


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"We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," the drug maker stated in the filing.