FDA 483 - Indoco Remedies Limited - November 21, 2018

An FDA inspection conducted from November 14-21, 2018, at Indoco Remedies Limited, a sterile and non-sterile drug product manufacturer in Verna, Goa, India, identified significant quality system deficiencies. Observations detailed in the FDA 483 report indicate inadequate procedures for managing drug product complaints, including the absence of a formalized process for extending investigations and a lack of validation for computerized tracking systems. The company also failed to ensure thorough review and investigation of discrepancies in production records, specifically regarding unit counts during media fill simulations. Furthermore, the quality control unit did not consistently follow its procedures, approving media fill batches and releasing production lines for commercial use prior to the completion and review of microbiological testing results. Changes to batch production control records were not fully implemented, leading to insufficient documentation of visual inspections and inadequate specifications for label rolls. Critically, the firm failed to submit Field Alert Reports within the mandated three-day timeframe for all batches potentially affected by incidents such as missing primary labels, despite identifying multiple impacted lots. These observations reflect deviations from established good manufacturing practices, necessitating comprehensive corrective actions by Indoco Remedies Limited to ensure compliance and product quality.