Dr Reddy's Gets Two Observations From US FDA For New York API Plant

US health regulator issues 2 observations after inspecting Dr Reddy's New York plant - Indiaweekly

HYDERABAD-BASED generics drug manufacturer Dr Reddy’s Laboratories on Saturday (17) said the US health regulator has issued a Form 483 with two observations after inspecting its US-based facility. The US Food and Drug Administration completed a Good Manufacturing Practice (GMP) inspection at the company’s API (active pharmaceutical ingredients) Middleburgh facility in New York from May 12-16, Dr Reddy’s said in a regulatory filing. “We have been…

Dr Reddy's Gets Two Observations From US FDA For New York API Plant

Dr. Reddy's Laboratories Ltd. on Saturday said the US health regulator has issued a Form 483 with two observations after inspecting its US-based facility.The US Food and Drug Administration completed a Good Manufacturing Practice inspection at the company's active pharmaceutical ingredients Middleburgh facility in New York, Dr Reddy's Laboratories said in a regulatory filing.The inspection was conducted during May 12-16, 2025, it added."We have …