FDA WARNING_LETTER - Conductive Technologies, Inc - March 12, 2014

On June 18, 2014, the FDA issued a Warning Letter to Conductive Technologies, Inc. following an inspection from March 4-12, 2014. The firm, a contract manufacturer of GenStrip Blood Glucose Test Strips, was found to have adulterated devices due to non-conformity with Quality System Regulation (21 CFR Part 820).

Key violations included: 1. **Management Responsibility (21 CFR 820.20(a)):** Failure of executive management to ensure an effective quality system, with inconsistent adherence to procedures for audits, complaint handling, design controls, CAPA, non-conformances, final acceptance, and document controls. Authority for final QA sign-off and lot release was undefined. 2. **Finished Device Acceptance (21 CFR 820.80(d)):** Inadequate procedures for finished device acceptance, including undocumented rationale for code assignment and lack of procedures to confirm completion of acceptance activities and authorized release. 3. **Design History File (21 CFR 820.30(j)):** Failure to demonstrate design development, including missing design plans, unincluded design input documents, lack of documentation for design output meeting input, inadequate design validation, and no assurance of design translation into production specifications. 4. **Risk Analysis (21 CFR 820.30(g)):** No risk management plan