FDA WARNING_LETTER - Continental Medical Labs, Inc. - February 08, 2013

An FDA inspection of Continental Medical Labs Inc. (Waterford, WI) on February 6-8, 2013, revealed that the firm's sterile and non-sterile convenience kits, classified as medical devices, were adulterated. The manufacturing, packing, storage, or installation methods did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System Regulation (QSR), 21 CFR Part 820. The firm's March 1, 2013, response to the FDA 483 was deemed inadequate for several issues. Key violations included: 1) Failure to validate processes with a high degree of assurance, specifically regarding sterilization re-validation, expiration dating, and seal parameters (21 CFR 820.75(a)). The firm continues distributing sterile kits without fully validated processes. 2) Failure to establish and maintain procedures for environmental control (21 CFR 820.70(c)). 3) Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)). 4) Failure to maintain complaint procedures that include evaluating for Medical Device Report (MDR) requirements (21 CFR 820.198(a)(3)). 5) Failure to establish and maintain procedures for controlling non-conforming product (21 CFR 820.90(a)). 6) Failure to conduct management reviews of the quality system (21 CFR 820.20(c)). The FDA requires prompt corrective actions, including a written response within 15 working days detailing specific steps, prevention plans, documentation, and a timetable for completion. Interim controls for distributing sterile kits are also requested. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, device approvals, and Certificates to Foreign Governments.