R82 A/S – FDA Warning Letter, Jun 7, 2013

On June 3-7, 2013, an FDA inspection of R82 A/S in Gedved, Denmark, revealed that their manufactured devices, including various wheelchairs, mechanical chairs, bath chairs, and standing frames, are adulterated under section 501(h) of the Act. This is due to non-conformity with Quality System regulation (21 CFR Part 820) for current good manufacturing practices.

Violations include: 1. Failure to verify/validate corrective and preventive actions (CAPA) effectiveness (21 CFR 820.100(a)(4)). For example, CAPAs #10686 and #10655 lacked documented verification of effectiveness. 2. Failure to review complaints for investigation necessity or document reasons for no investigation (21 CFR 820.198(b)). Complaints 10.942, 10.983, 9.967, 8.239, and 7.618 were not properly evaluated. 3. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). The firm could not provide required design documents for the Rabbit device. 4. Failure to control production processes to ensure device conformity (21 CFR 820.70(a)). No methods were provided for the