“We would like to inform the exchange that the United States Food and Drug Administration (USFDA) has conducted an inspection at our Bioequivalence Facility located at Vadodara from 3rd March 2025 to 7th March 2025. This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation,” Alembic Pharmaceuticals said in a regulatory filing.
The company stated that it will submit a comprehensive response to the FDA within the stipulated timeframe to address the observation. Alembic Pharma reiterated its commitment to maintaining the highest quality standards and regulatory compliance.
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What is a Form 483?
A Form 483 is a list of observations made during the inspection and is issued by the FDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. A Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Shares of Alembic Pharmaceuticals Ltd ended at ₹847.80, up by ₹36.70, or 4.52%, on the BSE.
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(Edited by : Shoma Bhattacharjee)
