Cadila’s Ahmedabad Plant Completes U.S. FDA Inspection With No Observations
The U.S. Food and Drug Administration inspected the company’s topical manufacturing facility in Ahmedabad.
Cadila Healthcare Ltd. on Friday said it has not received any observation from the U.S. health regulator after the inspection of its Ahmedabad manufacturing facility.
The U.S. Food and Drug Administration inspected the company's topical manufacturing facility in Ahmedabad during Dec. 16-20, 2019, the drug firm said in a BSE filing.
"At the end of the inspection, no observation (483) is issued ," it added.
As per the U.S. FDA, an FDA Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
It notifies the company's management of objectionable conditions at the inspected facility.
Shares of Cadila Healthcare closed at Rs 265.90 per scrip on the BSE, up 1.66 percent from its previous close.