FDA WARNING_LETTER - Rehabtronics Inc. - August 08, 2013

On August 5-8, 2013, an FDA inspection of Rehabtronics, Inc. in Edmonton, Alberta, Canada, revealed that their Saebo ReJoyce upper-extremity rehabilitation device was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820. The firm's August 28, 2013 response to the FDA 483 was deemed inadequate.

Violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** The CAPA procedure lacked requirements for analyzing quality data using statistical methodology to identify nonconforming product causes. The firm's proposed changes did not explain how data would be used or how statistical methods would detect recurring problems. 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a)):** (b)(4) complaints from 2011-2013 lacked Medical Device Report (MDR) evaluations. The firm failed to conduct a retrospective review for MDR reportability and did not provide revised procedures or evidence of implementation. 3. **Failure to investigate complaints (21 CFR 820.198(c)):** (b)(4) complaints