NSEDrug major Cipla Ltd announced on Friday (June 21) that the US Food and Drug Administration (USFDA) inspected its manufacturing facility in Goa, India, from June 10 to June 21, 2024.
After this inspection, Cipla received six inspection observations documented in Form 483.
"We hereby notify that the USFDA has conducted an inspection at the company's manufacturing facility in Goa, India from 10th – 21st June 2024.
On conclusion of the inspection, the company received six inspectional observations in Form 483," Cipla said in a regulatory filing.Cipla assured stakeholders that it will work closely with the USFDA to address these observations comprehensively within the stipulated timeframe.
During the closing conference, the inspector will communicate and explain these observations to the supplier.
NSE
Drug major Cipla Ltd announced on Friday (June 21) that the US Food and Drug Administration (USFDA) inspected its manufacturing facility in Goa, India, from June 10 to June 21, 2024. After this inspection, Cipla received six inspection observations documented in Form 483."We hereby notify that the USFDA has conducted an inspection at the company's manufacturing facility in Goa, India from 10th – 21st June 2024. On conclusion of the inspection, the company received six inspectional observations in Form 483," Cipla said in a regulatory filing.Cipla assured stakeholders that it will work closely with the USFDA to address these observations comprehensively within the stipulated timeframe. "The Company will work closely with the USFDA and is committed to addressing these comprehensively within the stipulated time," the statement added.A Form 483, a crucial part of the regulatory process, is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection. During the closing conference, the inspector will communicate and explain these observations to the supplier. However, Form 483 does not represent a final FDA determination regarding the facility's GMP compliance.Post Form 483 is issued, and the company is given 15 days to submit its response to the USFDA, explaining what steps the company will take to resolve the observations made by the USFDA.Shares of Cipla Ltd ended at ₹1,535.15, down by ₹9.30, or 0.60% on the BSE.
