FDA 483 - NATCO Pharma Limited - June 05, 2019

An FDA inspection of NATCO Pharma Limited, a sterile and non-sterile finished drug manufacturer in Rangareddy, India, revealed significant deficiencies across multiple systems. The firm failed to adhere to quality control unit responsibilities, maintain adequate laboratory controls, follow written procedures for annual product reviews and investigations, and ensure proper equipment calibration. These issues indicate a systemic lack of compliance with cGMP regulations.