Intercos America, Inc.October 9, 2024

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

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Record Details

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.

Company: Intercos America, Inc.
Inspection Date: October 9, 2024
Product Type: Drugs
Office: New York District Office
People: Syeda N. Mahazabin (Drug Investigator)
Emmanuel T. Donyina

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ID · df857bb7-7bc3-4cf6-b9c2-3007689027f6