USFDA issues Form 483 with 6 observations to Sun Pharma

The Company is preparing the response to the observations, which will be submitted to USFDA within the stipulated timeline., the company said.

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USFDA Form 483
USFDA Form 483

Last Updated on October 9, 2024 by The Health Master

Sun Pharmaceuticals Industries Limited has updated on U.S. Food and Drugs Administration (USFDA) Inspection at Mohali Facility.

As per the filing, the USFDA has conducted an inspection of the Mohali manufacturing facility (Punjab, India) of Sun Pharmaceutical Industries from August 3, 2022, to August 12, 2022.

At the conclusion of the inspection, the USFDA issued a Form-483, with 6 observations. 

The Company is preparing the response to the observations, which will be submitted to USFDA within the stipulated timeline., the company said.

It further added, “The Company is committed to addressing these observations promptly. The Company remains committed to working closely with the USFDA and continues to enhance its compliance on an ongoing basis.”

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