FDA WARNING_LETTER - CRS Medical Diagnostics, Inc. - December 28, 2007

On December 17-28, 2007, an FDA inspection of CRS Medical Diagnostics, Inc. in West Allis, Wisconsin, revealed that their Fibrin Analysis Catheter Testing Systems (FACTS) devices are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Process Validation (21 CFR § 820.75(a)):** Sterilization process validation lacked evaluation for non-pyrogenicity and sterile barrier integrity. 2. **Management Responsibility (21 CFR § 820.20(b)(2)):** Inadequate resources and trained personnel for Quality System implementation. 3. **Purchasing Controls (21 CFR § 820.50(a)(2)):** No procedures for controlling services/contractors, specifically lacking verification of sterilization for devices from the kit packer. 4. **Design Control (21 CFR § 820.30(a)):** No procedures for design activities (input, output, review, verification, validation, transfer). 5. **Design History File (21 CFR § 820.30(j)):** DHF for FACTS did not demonstrate design development per an approved plan or design control