Dr. Reddy’s biologics unit gets 9 U.S. FDA observations 

Dr. Reddy’s Laboratories has been issued a Form 483 with nine observations after a product specific pre-approval inspection of its biologics manufacturing facility in Bachupally, Hyderabad, by the U.S. Food and Drug Administration.

The inspection was conducted from October 4-12. “We have been issued a Form 483 with nine observations, which we will address within the stipulated timeline,” the drugmaker said on Thursday in a filing. On Friday, Dr. Reddy’s shares closed 1.25% lower at ₹5,461 apiece on the BSE.

Form 483 is issued by the U.S. FDA, on completion of inspection, to notify the company’s management of the objectionable conditions observed by its investigators that may constitute violations of the Food Drug and Cosmetic Act and related Acts.