FDA 483 - Indoco Remedies Limited - July 26, 2024

An FDA inspection of Indoco Remedies Limited in Vasco Da Gama, Goa, India, revealed significant deficiencies in both sterile and non-sterile drug manufacturing. Key issues included inadequate complaint investigations, failures in aseptic process validation, and a lack of adherence to quality control unit responsibilities. The firm also exhibited poor facility maintenance, insufficient environmental monitoring, and deficiencies in in-process material testing, indicating a broad range of cGMP violations.