Sun Pharma gets 6 USFDA observations for Mohali facility

Drugmaker, Sun Pharmaceutical Industries Limited, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with 6 observations at the company’s Mohali manufacturing facility (Punjab, India). The USFDA conducted an inspection from August 3, 2022 to August 12, 2022.
“At the conclusion of the inspection, the US FDA issued a Form-483, with 6 observations. The Company is preparing the response to the observations, which will be submitted to USFDA within the stipulated timeline,” the company stated 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.
“The Company is committed to address these observations promptly. The Company remains committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis,” the company informed.
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufacture and market a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult to make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates.
Source: Medicaldialogues