The United States Food and Drug Administration (USFDA) has inspected Neuland Laboratories’ Unit 3 manufacturing facility, located at Gaddapotharam village, Jinnaram, Sangareddy District, Telangana from August 10, 2026 to August 14, 2026.
At the conclusion of the inspection, the USFDA issued a Form 483 with one observation. The observation pertains to procedural improvements in water and environmental monitoring to include new organisms beyond those listed in the United States Pharmacopeia (USP).
Neuland Laboratories is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry’s chemistry needs.