FDA 483 - Indoco Remedies Limited (Plant I) - January 25, 2019

Indoco Remedies Limited (Plant I) in Vasco Da Gama, Goa, a tablet manufacturer, was inspected and cited for significant data integrity issues and inadequate quality control. Observations included purposeful recording of inaccurate manufacturing data, failure to thoroughly investigate discrepancies and OOS results, and incomplete laboratory and batch records. The inspection revealed systemic problems in data management, record-keeping, and procedural adherence.