USFDA concludes inspection at Sun Pharmaceutical Industries’ Mohali facility

16 Aug 2022 Evaluate

United States Food and Drug Administration (USFDA) has concluded an inspection at Sun Pharmaceutical Industries’ Mohali manufacturing facility (Punjab, India) 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 US FDA within the stipulated timeline. The company is committed to address these observations promptly. The Company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis.

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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