FDA 483 - Indoco Remedies Limited (Plant I) - October 18, 2023

Indoco Remedies Limited (Plant I) in Verna Da Gama, Goa, India, was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed failures in equipment cleaning and maintenance, inadequate visual inspection programs for drug products, and a lack of thorough investigation into out-of-specification results and discrepancies. Additionally, the firm's quality control unit demonstrated a failure to fully follow its procedures, impacting data integrity and record-keeping.