Sun Pharma gets 10 USFDA observations for Halol facility
Mumbai: Pharma major, Sun Pharma, today announced that US Food and Drug Administration (USFDA) has recently concluded the Good Manufacturing Practices (GMP) inspection with 10 observations at the company's Halol facility situated in Gujarat, India.
The inspection was conducted from April 26 to May 9, 2022.
"We hereby inform you that the USFDA 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 USFDA issued a Form-483, with 10 observations," the company said in its recent BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Read also: USFDA successfully concludes inspection at Alkem Labs Taloja Bioequivalence Center
"The Company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days", Sun Pharma 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 GMP compliance on an ongoing basis," the firm further added.
Read also: Sun Pharma to market its own version of Vortioxetine, signs agreement with Lundbeck
