The US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited’s Halol facility (Gujarat, India) from April 26 to May 9, 2022. At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations.
The Company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. The Company is committed to addressing these observations promptly. The Company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis.