Sun Pharmaceutical Industries Ltd - 524715 - Update On US FDA Halol Lnspection
We hereby inform you that the US FDA conducted a Good Manufacturing Practices {GMP) inspection of Sun Pharmaceutical Industries ltd.''s Halol facility (Gujarat, India) from December 03-13, 2019. At the conclusion of the inspection, the agency issued a Form 483, with eight 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.13-12-2019
