AHMEDABAD, DEC 22
City-based pharma major Cadila Healthcare on Friday said it has not received any observation from the US health regulator after the inspection of its Ahmedabad manufacturing facility. The United States Food and Drug Administration (USFDA) inspected the company’s topical manufacturing facility in Ahmedabad during December 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 USFDA, 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.
