Pharma major Cipla Ltd on Monday (January 20) announced that the United States Food and Drug Administration (FDA) conducted an inspection of its wholly-owned subsidiary, Medispray Laboratories Private Ltd, located in Kundaim, Goa, from January 14-20, 2025.

“…we hereby notify that United States Food and Drugs Administration (‘USFDA’) has conducted an inspection at the manufacturing facility of Medispray Laboratories Private Limited, wholly owned subsidiary of the Company (‘Medispray’) located in Kundaim, Goa from 14th – 20th January, 2025,” Cipla said in a regulatory filing.

Following the inspection, the facility received one observation in Form 483. Cipla stated its commitment to working closely with the FDA to address the observation comprehensively within the stipulated timeline.

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“On conclusion of the inspection, Medispray received 1 (one) observation in Form 483. The Company will work closely with the USFDA and remains committed to address these observations comprehensively within stipulated time,” Cipla added.

What is Form 483

Form 483 is a list of observations made during the inspection and is issued by the FDA inspectors following 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.

After Form 483 is issued, the company is given 15 days’ time to submit its response to the FDA explaining what steps the company will take to resolve the observations made by the US regulator.

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Shares of Cipla Ltd ended at ₹1,445.90, was by ₹3.45, or 0.24%, on the BSE.