The U.S. Food and Drug Administration notified Sun Pharmaceutical Industries Ltd. of objectionable conditions at its Halol facility in Gujarat, India, following a reinspection.
The regulator conducted the Good Manufacturing Practices inspection of the company's facility from Feb. 12-23, and issued a Form 483, with three observations. A Form 483 is issued to a company at the end of an inspection if the investigator observed a condition that could be a violation of the Food Drug and Cosmetic Act and related acts.
Most of the India-based generics drugmaker's new products for the U.S. are launched from the Halol plant, but the launches were stopped after the company received a warning in 2015 for violating manufacturing standards, Fierce Pharma reported. Further, a reinspection in 2016 yielded 10 observations.
Sun Pharma said Feb. 23 that it is preparing its response to the new observations and will submit it to the FDA within 15 days.