Mumbai: Sun Pharmaceutical Industries Limited has announced that US Food and Drugs Administartion (USFDA) has issued eight observations for its Halol facility at the conclusion of the inspection. A Good Manufacturing Practices (GMP) inspection was conducted from 02 June to 13 June 2025.”We hereby inform that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun
Pharmaceutical Industries Limited’s Halol facility (Gujarat, India) from 02 June to 13 June 2025. At the
conclusion of the inspection, the US FDA issued a Form-483, with 8 observations,” the company stated in a 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: Sun Pharma scores USFDA nod for Next Generation BLU-U Blue Light Photodynamic Therapy Illuminator for Actinic KeratosisSun Pharma is a specialty generics company with a presence in specialty, generics and consumer healthcare products. Sun Pharma’s global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. Its manufacturing facilities are spread across six continents.Read also: Sun Pharma Sets Record with Over 1 Lakh Uric Acid Screenings in 3 Days