Syntron Bioresearch Inc. – FDA Warning Letter, Jan 21, 2010

On May 24, 2010, the FDA issued a Warning Letter to Syntron Bioresearch Inc. following an inspection from January 11-21, 2010. The inspection found that Syntron's drug abuse test kits, classified as devices, were adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) Good Manufacturing Practice (CGMP) requirements.

Key violations included: 1. **Process Validation (21 CFR 820.75(b)):** Failure to identify process parameters for lyophilization. 2. **Complaint Handling (21 CFR 820.198(c)):** Inadequate investigation of customer complaints regarding wrong pipettes, ink spots, migration failures, and incorrect package inserts. 3. **Nonconforming Product (21 CFR 820.90(a)):** Failure to control nonconforming product, a repeat observation, with rejected raw materials released to the warehouse without proper documentation. 4. **Acceptance Activities (21 CFR 820.80(e)(3)):** Inadequate documentation of incoming product acceptance, lacking measurements and test results. 5. **Incoming Product Acceptance (21 CFR 820.80(b)):** No