EPS Biotechnology Corp. – FDA Warning Letter, Jun 21, 2012

On October 19, 2012, the FDA issued a Warning Letter to EPS Biotechnology Corp. following an inspection from June 18-21, 2012, which found their glucose dehydrogenase glucose meters to be adulterated. The inspection revealed non-conformity with Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish adequate procedures for receiving and evaluating complaints. U.S. complaints were not forwarded to EPS, and their revised SOP lacked evidence of employee training, corrective action, or a retrospective review of past complaints. 2. **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate processes, specifically for Easy Plus Mini/Glucose test strips, where worst-case conditions were not included. The response lacked evidence of training, corrective action, systemic review, or proper process validation. 3. **Design Validation (21 CFR 820.30(g)):** Failure to validate device design using initial production batches or equivalents for the DO44 EME Self Monitoring Glucose Meter. The response did not provide evidence of training, corrective action, systemic review, or proper design validation. 4. **Rework Procedures (21 CFR 820.90(b)(2)):**