LumiQuick Diagnostics Inc. – FDA Warning Letter, Feb 24, 2014

On April 1, 2014, the FDA issued a Warning Letter to LumiQuick Diagnostics, Inc. following an inspection from February 4-24, 2014. The inspection revealed that the firm's manufactured diagnostic test cards, including those for cancer markers, infectious pathogens, cardiac markers, and drugs of abuse, are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate device design (21 CFR 820.30(g)):** For example, the Malaria Antigen Test design history file lacked studies to assess "ease of use," and performance data did not support conclusions of 100% sensitivity and specificity, despite reported failures. The firm's response was deemed inadequate as it lacked revised SOPs or evidence of corrections. 2. **Failure to control design changes (21 CFR 820.30(i)):** A Malaria buffer volume change lacked an approved protocol and supporting raw data. The firm's response was inadequate due to missing documentation. 3. **Failure to transfer design to production specifications (21 CFR 820.30(h)):** Work instructions for QC testing of Syphilis, Dengue, and PSA test cards lacked identification of controls and specifications from the design history file