Recipient: Verichem Laboratories Inc.
Product: clinical chemistry reference materials for in-vitro diagnostic (IVD) use
1. Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g).
b) Your firm failed to perform design validation for the data analysis software used in the Cal Ver EP Evaluator to determine out of specification stability results for Verichem products.
FDA office: New England District Office