Dr. Reddy’s Laboratories active pharmaceutical ingredients (API) plant in Srikakulam, Andhra Pradesh, has been issued a Form 483 with four observations by the U.S. Food and Drug Administration.
“The U.S. FDA today completed a GMP inspection at our API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The inspection was conducted from May 30 to June 7. We have been issued a Form 483 with four observations, which we will address within the stipulated timeline,” the drugmaker said in a filing on Friday. Dr. Reddy’s closed 2.75% at ₹6,059.05 each on the BSE.
The U.S. FDA issues Form 483 notifying the respective company’s management of the objectionable conditions, on conclusion of an inspection, observed by its investigators that may constitute violations of the Food Drug and Cosmetic Act and related Acts.
