FDA 483 - Centaur Pharmaceuticals Private Ltd. - July 25, 2025

Centaur Pharmaceuticals Private Limited, a drug substance manufacturer in Ambernath (W), India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate Out-of-Specification (OOS) investigations, a deficient stability monitoring program, and insufficient process validations. These issues led to the distribution of API batches without proper stability data or adequate process controls.