Dr. Reddy’s reported in a filing with the Bombay Stock Exchange that it received a Form 483 from the FDA on Feb. 8 with 11 observations after an inspection of its Bachupally, Hyderabad facility.
The inspection report has not yet been made public, but Dr. Reddy’s confirmed the violations and said it would address them within the stipulated timeline. The FDA previously cited the facility for 11 violations in a 2017 inspection.
Last September, the FDA found eight violations at a Dr. Reddy’s facility in Duvvada, Andhra Pradesh. That facility was also cited in 2015 along with two others over potential contamination.