FDA 483 - Paradox Inc - October 11, 2024

Paradox Inc, a contract laboratory in Saint Joseph, MO, was cited for significant deficiencies during an FDA inspection. Observations included failures in maintaining electronic data backups and audit trails, inadequate investigations into out-of-specification results and discrepancies, and a lack of adherence to quality control procedures and data integrity principles. Additionally, the facility exhibited poor maintenance, with samples stored improperly and water damage observed in the laboratory.