Paradox Inc – FDA 483, Oct 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.
ID · 157d4ae1-9241-4537-a6b2-afe0a6527d84
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