# US FDA flags 3 issues at Dr Reddy’s Srikakulam plant

2026-08-08T05:53:59+00:00 | Governance | Indian Opinion Desk

Corroboration: 1 independent outlet

Dr Reddy’s Laboratories has received three observations from the US Food and Drug Administration after an inspection at its Srikakulam facility in Andhra Pradesh. The Pre-Approval Inspection and Good Manufacturing Practices check were carried out from July 20 to July 29, the company said in a filing on July 29. The regulator issued a Form 483 with three observations, which the drugmaker said it would address within the stipulated timeline. Shares of Dr Reddy's closed flat at Rs 1,144.35 on the BSE on Thursday. The facility is the FTO-SEZ Process Unit-02.

## Coverage

- thehindu.com <https://www.thehindu.com/business/Industry/dr-reddys-srikakulam-facility-gets-3-us-fda-observations/article71286036.ece>

Tags: Dr Reddy's, Form 483, GMP inspection, pharma regulation, Srikakulam, US FDA
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