TEM INNOVATIONS GMBH – FDA Warning Letter, Oct 22, 2014

On April 21, 2015, the FDA issued a Warning Letter to Tem Innovations GmbH following an inspection from October 20-22, 2014, which revealed violations of the Quality System (QS) regulation (21 CFR Part 820) for their ROTEM delta Whole Blood Hemostasis System. The devices were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Nonconforming Product Control (21 CFR 820.90(a)):** The firm failed to control nonconforming Rotrol P diluent units (lot # 41819801), distributing them after identifying nonconformance without proper disposition or documented corrective actions. The firm's response was inadequate as it lacked evidence of corrections for identified nonconformities and a comprehensive retrospective review plan. 2. **Complaint Handling (21 CFR 820.198(a)):** The firm did not follow its own "Customer Complaint" SOP, failing to categorize and handle complaints as required. The response was inadequate, lacking evidence of corrections for specific complaints, staff training on revised procedures, and a retrospective review of all complaints. 3. **Supplier Management (21 CFR 820.50(a)):** The firm failed to audit a critical supplier, (b