U.S. Drug Regulator Completes Audit Of Dr. Reddy’s Louisiana-Based Facility
Dr. Reddy's Laboratories on Friday said the U.S. drug regulator has completed the audit of its Louisiana-based formulations manufacturing facility, following which no Form 483 was issued.
The audit of our formulations manufacturing facility at Shreveport, Louisiana, U.S. by the U.S. Food And Drug Administration, has been completed on Aug. 8, the company said in a regulatory filing. No Form 483 was issued at the end of the inspection, the company added.
As per the U.S. FDA, Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
It notifies the company's management of objectionable conditions.