Diagnostics Biochem Canada, Inc. – FDA Warning Letter, Sep 9, 2011

On December 20, 2011, the FDA issued a Warning Letter to Diagnostics Biochem Canada, Inc. following an inspection from September 6-9, 2011. The inspection revealed that the firm's Aldosterone ELISA, Free Testosterone ELISA, and Dihydrotestosterone ELISA kits are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to adequately validate device design (21 CFR 820.30(g))**: The firm's validation protocol was not implemented for the PRA ELISA test kit, lacking documented methods, statistical rationales, and acceptance criteria. The firm's corrective actions (CAR#19-2011, CAR#13-2011) were incomplete by the November 15, 2011, deadline. 2. **Failure to establish design transfer procedures (21 CFR 820.30(h))**: No design transfer procedures were available or documented. Corrective action (CAR #12-211) to draft a new SOP was incomplete by November 15, 2011. 3. **Failure to establish acceptance activity procedures (21 CFR