USFDA Flags Dr. Reddy's API Facility with Four Observations

Dr. Reddy's Laboratories reported that the USFDA issued Form 483 with four observations after inspecting its API manufacturing facility in Andhra Pradesh. The inspection took place from May 30 to June 7, 2024. The company committed to addressing these observations within the stipulated timeline.

Dr. Reddy's Laboratories revealed on Friday that the US Food & Drug Administration (USFDA) has issued Form 483 containing four observations following an inspection of its Active Pharmaceutical Ingredient (API) manufacturing facility located in Andhra Pradesh.

Conducted between May 30 and June 7, 2024, the inspection aimed to ensure compliance with Good Manufacturing Practices (GMP). The Hyderabad-based pharmaceutical giant confirmed in a regulatory filing that it would address the observations within the stipulated timeline.

Form 483 is typically issued at the end of an inspection when the investigator identifies conditions that could violate the Food, Drug, and Cosmetic Act and related regulatory statutes.