Shanghai Shunlong Physical Therapy Equipment Co. Ltd. – FDA Warning Letter, Oct 20, 2011

On October 17-20, 2011, an FDA inspection of Shanghai Shunlong Physical Therapy Equipment Co. in China, a manufacturer of Class II patient care beds and Class I manual wheelchairs and walkers, revealed that its devices were adulterated under 21 U.S.C. § 351(h). The firm's manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints, specifically regarding documentation of oral complaints and MDR reportability evaluations. The firm's responses were inadequate, lacking evidence of implemented systemic corrective actions. 2. **Design Review (21 CFR 820.30(e)):** Failure to establish adequate procedures for formal, documented design reviews at appropriate stages, including required participant representation. The firm's responses were inadequate, lacking evidence of implemented systemic corrective actions for design reviews. 3. **Design Validation (21 CFR 820.30(g)):** Failure to establish adequate procedures for validating device design, including establishing acceptance criteria, documenting validation results, and verifying production unit testing. The firm's responses were inadequate, lacking evidence of implemented systemic corrective actions