Dr Reddy's gets 8 observations from US FDA for Duvvada plant

Drug major Dr Reddy's Laboratories (DRL) on Friday said the US health regulator has issued eight observations after inspecting its facility in Duvvada near Visakhapatnam. The inspection was carried out in the last week of October for 8-9 days.

Last year in November, Dr Reddy’s said US FDA had issued a procedural Establishment Inspection Report (EIR) to Duvvada facility following the plant audit in March 2017 but the inspection has not been closed and warning letter on the unit stays on.

In March audit of the facility, the US FDA had issued a Form 483 with 13 observations relating to deviations from current good manufacturing practices (cGMP).