USFDA issues Form 483 with four observations to Dr Reddy's API unit

Dr Reddy's Laboratories on Friday said the US health regulator has issued Form 483 with four observations after inspecting its Andhra Pradesh-based API manufacturing facility.

The US Food & Drug Administration (USFDA) today completed a GMP inspection at the company's API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh, the Hyderabad-based drug major said in a regulatory filing.

The inspection was conducted from May 30, 2024 to June 7, 2024, it added.
 

"We have been issued a Form 483 with four observations, which we will address within the stipulated timeline," the drug firm said.

As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.