# FDA WARNING_LETTER - Diagnostics Biochem Canada, Inc. - September 09, 2011

Source: https://www.keypedia.com/records/warning_letter/diagnostics-biochem-canada-inc/5b35237c-8eda-49ec-881f-2c244e53980b

> FDA WARNING_LETTER for Diagnostics Biochem Canada, Inc. on September 09, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Diagnostics Biochem Canada, Inc.
- Inspection Date: 2011-09-09
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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