Two formulations manufacturing facilities of generic drugmaker Dr. Reddy’s Laboratories in Visakhapatnam have been issued a Form 483 with two observations by the United States Food and Drug Administration (FDA).
The observations had been issued by U.S. FDA on completion of “a routine GMP inspection at our formulations manufacturing facilities (FTO-7 and FTO-9) in Duvvada, Visakhapatnam,” Dr. Reddy’s stated in a submitting on Friday.
“The inspection was conducted from May 8-17. We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,” it stated.
According to the U.S. FDA, it issues Form 483, on conclusion of an inspection, notifying the respective firm’s administration of the objectionable circumstances noticed by its investigators which will represent violations of the Food Drug and Cosmetic Act and associated Acts.
