FDA 483 - Intercos America, Inc. - October 09, 2024

An FDA inspection of Intercos America, Inc., an OTC manufacturer in Congers, NY, revealed significant deficiencies in the control of computerized systems. The firm failed to implement appropriate controls to prevent unauthorized data deletion, lacked procedures for reviewing audit trails, and had no system for backing up electronic data. These issues raise concerns about data integrity and the reliability of records.