The U.S. FDA has made three observations on possible violations after an audit of Dr.Reddy’s Laboratories API plant in Miryalaguda, DRL said.The audit of the plant by U.S. FDA was completed on February 21.
Form 483 is issued at the “conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.” Through its issue, the company’s management is notified of the objectionable conditions.
“Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously,” according to the regulator.
