FDA WARNING_LETTER - R&D; Engineering Of Earlham Inc - May 01, 2014

On April 17-May 1, 2014, an FDA inspection of R&D Engineering of Earlham, Inc. identified significant deviations from medical device current good manufacturing practice regulations (21 CFR Part 820) for their suction canister and lid, and kidney transport tray devices. These deviations render the devices adulterated under Section 501(h) of the Act.

The primary issue is a lack of Quality System procedures and instructions (21 CFR 820.20(e)). Specific violations include: 1. Failure to ensure identification labels on each device (21 CFR 820.60). 2. Failure to establish complete Device Master Records (21 CFR 820.181) and Device History Records (21 CFR 820.184) for both products. 3. Failure to establish acceptance activities for incoming raw materials (21 CFR 820.80(b)). 4. Failure to establish acceptance activities for in-process and finished devices (21 CFR 820.80(c), 820.80(d)). 5. Failure to document evaluation or quality requirements of suppliers (21 CFR 820.50(a)). 6. Failure to calibrate manufacturing equipment, specifically a scale (21 CFR 820.