Drug firm Alkem Laboratories Ltd on Wednesday (March 27) said the US Food and Drug Administration (USFDA) conducted an inspection at its manufacturing facility located in Baddi from March 19 to March 27, 2024.
At the conclusion of the inspection, the company received a Form 483 with ten observations, according to a stock exchange filing.
"This is to inform you that USFDA had conducted an inspection at the company’s manufacturing facility located at Baddi from 19th March 2024 to 27th March 2024. At the end of the inspection, the company has received Form 483 with ten (10) observations," Alkem Laboratories said.
The inspection covered both Good Manufacturing Practices (GMP) and a Pre-Approval Inspection. Notably, there were no observations related to data integrity.
In response to the findings, Alkem Laboratories stated that this inspection is a part of routine business operations. The company has committed to submitting a detailed response to the USFDA within the stipulated timeline and closing out the observations.
"This Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," Alkem Laboratories added.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection.
The inspector will communicate and explain these observations to the supplier during the closing conference. However, Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Post Form 483 is issued, the company is given 15 days time to submit its response to the USFDA explaining what steps will the company take to resolve the observations made by the USFDA.
Shares of Alkem Laboratories Ltd ended at ₹5,011.90, up by ₹9.70, or 0.19% on the BSE.
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