FDA EIR - Paradox Inc - August 04, 2021

An FDA inspection of Paradox Inc., D.B.A Custom Industrial Analysis Labs Inc. (CIA Labs) was conducted from August 2-4, 2021, revealing significant compliance deficiencies. Operating as a contract testing laboratory for human and animal drug products, the company received a four-item FDA 483 for violations under the regulatory framework of 21 CFR Part 211 (Good Manufacturing Practices). Main issues included a lack of established and documented accuracy, sensitivity, specificity, and reproducibility for analytical test methods, with both in-house and USP methods lacking proper validation or verification. The inspection also identified failures in thoroughly reviewing unexplained discrepancies, specifically regarding inadequate corrective and preventive actions for recurring analyst errors and inaccuracies on Certificates of Analysis (COAs). Additionally, the quality control unit did not consistently adhere to its procedures, evidenced by unreviewed stability chamber monitoring charts and uninvestigated humidity deviations. Lastly, electronic spreadsheets used for critical chromatography calculations lacked validation and essential security controls to prevent unauthorized modifications. Management acknowledged these observations and committed to implementing corrective actions, including validating test methods and securing computer systems. A formal written response detailing these actions is required within 15 business days, and management was reminded of their responsibility to comply with the FD&C Act.