FDA 483 - Indoco Remedies Limited (Plant I) - January 20, 2023

Indoco Remedies Limited (Plant I) in Vasco Da Gama, Goa, India, was cited for significant deficiencies during an FDA inspection from January 16-20, 2023. The observations highlight systemic failures in quality control, including inadequate investigations into equipment breakdowns, compromised data integrity, and insufficient oversight of manufacturing processes and laboratory controls. These issues collectively indicate a lack of assurance regarding the safety, effectiveness, and quality of the drug products manufactured.