FDA 483 - Indoco Remedies Limited - November 21, 2018

An FDA inspection of Indoco Remedies Limited, a sterile and non-sterile drug product manufacturer in Verna, Goa, revealed significant deficiencies in their quality system. Observations included inadequate procedures for handling and investigating drug product complaints, unvalidated computerized systems for complaint management, and a lack of formal processes for transcribing complaint data. Furthermore, the firm failed to thoroughly investigate discrepancies in production records, did not review microbiological testing results prior to batch approvals, and did not fully implement changes to batch production records or submit Field Alert Reports in a timely manner for all affected batches.