FDA EIR - NATCO Pharma Limited - June 19, 2025

An FDA inspection of NATCO Pharma Limited, located in Rangareddy, Telangana, India, was conducted from June 9 to June 19, 2025. This unannounced, for-cause inspection focused on sterile and non-sterile drug manufacturing, following guidelines such as CP 7356.002 and 7356.002A for drug manufacturing and sterile drug process inspections. The inspection identified seven significant violations, documented in an FDA 483 form.

Key issues included critical deficiencies in the environmental monitoring system for aseptic processing areas, specifically concerning data integrity. Instances were noted where electronic data for non-viable particle counts were altered from failing to passing results in official hardcopy reports attached to batch records. Additionally, retesting without proper justification or documentation, and the omission of relevant environmental monitoring data from batch documentation, were observed. Other violations included inadequate maintenance of equipment and utensils, insufficient validation of aseptic processes, and a repeated failure to thoroughly investigate unexplained discrepancies and batch specification failures. Furthermore, the company lacked established and followed procedures to prevent microbiological contamination in sterile products, had unsuitable building construction for proper operations, and exhibited deficiencies in written procedures for its quality control unit.

NATCO Pharma Limited management acknowledged the observations and committed to implementing corrective actions, with a written response due within 15 business days.