FDA 483 - Paradox Inc - August 04, 2021

Paradox Inc., D.B.A Custom Industrial Analysis Labs Inc, a contract testing laboratory in Saint Joseph, MO, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed failures in method validation, discrepancy investigations, quality unit procedures, and computer system controls. These issues indicate a lack of robust quality systems necessary to ensure the reliability and integrity of testing results.