Aarti Drugs Ltd on Friday (November 6) said its subsidiary, Pinnacle Life Science Private Ltd, received three inspectional observations in Form 483 from the United States Food and Drug Administration (US FDA) following an inspection of its formulations manufacturing facility in Baddi, Himachal Pradesh.
The US FDA inspected the facility from November 2 to November 6, 2026. Aarti Drugs said none of the three observations was related to data integrity and that the company would work closely with the US regulator to resolve all the points.
In a regulatory filing, Aarti Drugs said the observations would have no impact on the financial, operational or other activities of the company. It also stated that there was no financial or operational impact on Pinnacle Life Science. The company received the Form 483 communication on November 6, the date on which the inspection concluded.
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Aarti Drugs said it would work closely with the US FDA to address the three inspectional observations received at the conclusion of the inspection. The company did not specify the individual observations in its filing. It reiterated that none of the points was related to data integrity.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors post the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a 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 USFDA.
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Shares of Aarti Drugs Ltd ended at ₹445.90, up by ₹1.60, or 0.36%, on the BSE.