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Dr Reddy's Laboratories Receives Two USFDA Observations for Andhra Pradesh Plant
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News18•08-10-2026, 17:45
Dr Reddy's Laboratories Receives Two USFDA Observations for Andhra Pradesh Plant
- •Dr Reddy's Laboratories received a Form 483 with two observations from the US Food and Drug Administration.
- •The observations followed a Pre-Approval Inspection at the company's FTO-11 manufacturing unit in Pydibhimavaram, Andhra Pradesh.
- •The inspection by the US health regulator took place from October 5 to October 7.
- •The drug maker stated that it will address the observations within the stipulated timeline.
Key Questions Answered
The US Food and Drug Administration completed a Pre-Approval Inspection at Dr Reddy's Laboratories' FTO-11 manufacturing unit in Pydibhimavaram, Andhra Pradesh, which resulted in a Form 483 with two observations.
The US health regulator issued a Form 483 containing two observations following the inspection of the manufacturing facility located in Pydibhimavaram, Andhra Pradesh.
Dr Reddy’s Laboratories stated in a regulatory filing that it will address the two observations within the stipulated timeline.
