FDA WARNING_LETTER - Verichem Laboratories, Inc. - October 29, 2010

On December 16, 2010, the FDA issued a Warning Letter to Verichem Laboratories Inc. following an inspection from September 14 to October 29, 2010. The inspection determined that Verichem Laboratories Inc. manufactures and contract manufactures clinical chemistry reference materials for in-vitro diagnostic (IVD) use, classifying them as medical devices. The products Verichem Ethanol Standard Kit 9670, Verichem Enzyme ER Verifier Kit 9410, and Multi-Enzyme Verifier Kit 9440 were found to be adulterated under section 501(h) of the Act, due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to validate design (21 CFR 820.30(g)):** * Failure to conduct or document a stability study on original validation lots for the Verichem Ethanol Standard Kit 9670. * Failure to perform design validation for the data analysis software used in the Cal Ver EP Evaluator. 2. **Failure to control nonconforming product (21 CFR 820.90(a)):** * Failure to maintain a procedure to evaluate, investigate, and document non