FDA WARNING_LETTER - Verichem Laboratories, Inc. - November 14, 2014

On February 4, 2015, the FDA issued a Warning Letter to Verichem Laboratories Inc. following an inspection from October 14 to November 14, 2014. The inspection revealed that the firm's clinical chemistry reference materials (calibrators and calibration verifiers), classified as Class 1 and 2 IVD devices, were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

The Warning Letter detailed nine violations, stating that the firm's December 8, 2014, response to the FDA 483 was inadequate for all points. Key violations included: 1. Failure to establish and maintain procedures for validating device design (21 CFR 820.30(g)), exemplified by unvalidated material changes, inadequate stability testing for multiple products, and a lack of validation for a cap design change that caused product issues. 2. Failure to adequately maintain device master records (21 CFR 820.181), with examples of incomplete material specifications and conflicting revisions for product specifications. 3. Failure to establish and maintain procedures to control all required documents (21 CFR 820.40), such as delayed documentation of design plans and engineering change requests. 4. Failure to ensure equipment meets requirements (