FDA WARNING_LETTER - R82 A/S - October 07, 2010

On March 14, 2011, the FDA issued a Warning Letter to R82 A/S following an inspection from October 4-7, 2010, at their Gedved, Denmark facility. The inspection revealed that R82 A/S, a manufacturer of pediatric mobile standing frames, wheelchairs, gait trainers, and toilet/bath accessories, was not in conformity with the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. Failure to establish and maintain adequate rework procedures, including retesting and reevaluation of nonconforming products (21 CFR 820.90(b)(2)). 2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA), specifically verifying and validating CAPA effectiveness (21 CFR 820.100(a)(4)). 3. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, including determining MDR reportability (21 CFR 820.198(a)(3)). 4. Failure to review, evaluate, and investigate complaints involving possible device failure, labeling, or packaging issues (21 CFR 820.198(c)). 5.