Dr Reddy's API Unit in Telangana Gets 2 USFDA Observations

Key Highlights:

• Dr. Reddy's API plant in Telangana received a Form 483 with two observations from the USFDA.
• The inspection at the Miryalaguda facility was conducted from May 19 to May 24, 2025.
• The company has committed to addressing the USFDA’s observations within the stipulated timeline.

After a close inspection of its active pharmaceutical ingredient (API) manufacturing unit, Dr. Reddy’s Laboratories has received a Form 483 with two observations from the US Food and Drug Administration (USFDA).

The Hyderabad-based pharma giant made a condemnation regarding the matter late on Saturday in a stock exchange declaration. The inspection occurred at its CTO-5 manufacturing unit in Miryalaguda, Telangana, for six days, from May 19 to May 24, 2025.

Also read: The Future of Green Chemistry in API Production

"We have been issued a Form 483 with 2 observations, which we will address within the stipulated timeline," Dr Reddy's Laboratories said. The firm has not disclosed the specific nature of the observations but assured that it remains committed to maintaining high standards of compliance and quality.

USFDA inspectors issue a Form 483 to the company at the conclusion of an inspection where the inspectors are concerned that there could be potential violations of the Food, Drug, and Cosmetic (FD&C) Act or related regulatory requirements. The issuance of a Form 483 means that the inspectors could expect some level of Corrective Action, but it does not mean that there will be immediate enforcement action.