The U.S. Food and Drug Administration (USFDA) has issued a Form 483 with one observation to the API manufacturing plant of Dr. Reddy’s Laboratories in Miryalaguda, Telangana.
The certificate was issued on completion of an audit of the facility. “We have been issued a Form 483 with one observation, which we are addressing, the company said in a regulatory filing on Monday.
Through a Form 483, the USFDA notifies objectionable conditions, which may constitute violation of the provisions, observed by its investigators during an audit, to the management of the company.