Voss Plastics, Inc. – FDA Warning Letter, Sep 12, 2014

On September 8-12, 2014, an FDA inspection of Voss Plastics, Inc. in Helotes, Texas, a contract manufacturer of disposable coronary by-pass cannulas, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803). The devices were deemed adulterated and misbranded.

Key QS violations included: 1. Failure to establish procedures for validating the (b)(4) manufacturing process (21 CFR 820.75(a)). 2. Failure to establish procedures for controlling and monitoring production processes, including visual inspection (21 CFR 820.70(a)). 3. Failure to establish acceptance activities for manufacturing (21 CFR 820.80(a)). 4. Failure to establish procedures for controlling nonconforming product (21 CFR 820.90(a)). 5. Failure to establish procedures for corrective and preventive actions (21 CFR 820.100(a)). 6. Failure to establish procedures for reviewing and evaluating complaints (21 CFR 820.198(a)). 7. Failure to establish procedures to maintain device history records (21 CFR 820.184). 8. Failure to establish procedures for quality audits (