FDA 483 - International Laboratories Corp - September 20, 2024

International Laboratories Corp, an OTC drug manufacturer in Bang Phli, Thailand, was cited for severe data integrity and quality control deficiencies during an FDA inspection. Observations included fabricated and backdated OOS investigations, lack of complete laboratory records and data traceability, and inadequate controls over computer systems and master records. The firm also failed to establish essential written procedures for production, process controls, and quality unit responsibilities.