USFDA conducts GMP inspection at Sun Pharma’s Halol facility

10 May 2022 Evaluate

The United States Food and Drug Administration (USFDA) has conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries’ Halol facility (Gujarat, India) from April 26 to May 9, 2022.

At the conclusion of the inspection, the USFDA issued a Form-483, with 10 observations. The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days. The company is committed to addressing these observations promptly and also remains committed to working closely with the USFDA and continues to enhance its GMP 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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