Dr. Reddy's receives three USFDA observations at Visakhapatnam plant

The US Food and Drug Administration (USFDA) issued a Form 483 with three observations following a pre-approval inspection at Dr. Reddy’s Laboratories’ FTO-9 manufacturing facility in Visakhapatnam, Andhra Pradesh. The inspection took place from October 8 to October 9, 2026.

A Form 483 is a notice issued by investigators listing conditions that may constitute violations of regulatory requirements; it is not a formal fine or ban and allows the company to provide a corrective response. Dr. Reddy’s has stated it will address the observations within the required timeline, though the specific details of the findings have not been disclosed.

The FTO-9 plant is a key component of the company’s manufacturing network. This regulatory update follows other recent USFDA inspections at different Dr. Reddy’s facilities, including observations at the Pydibhimavaram and Srikakulam plants earlier this year.