FDA WARNING_LETTER - Foshan R. Poon Medical Products Co., Ltd. - February 10, 2012

On February 7-10, 2012, an FDA inspection of Foshan R. Poon Medical Products Co., Ltd. in China revealed significant violations for their semi-electric hospital beds and powered wheelchairs. The semi-electric hospital beds were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations for semi-electric hospital beds included: 1. **Corrective and Preventive Action (CAPA) deficiencies (21 CFR 820.100(a)):** Procedures lacked requirements for verifying/validating CAPA effectiveness and documenting implementation. Twelve CAPAs reviewed lacked verification/validation and documented implementation. Data analysis procedures were incomplete, only analyzing non-conforming products and customer satisfaction, omitting other quality data sources like complaints and audit results. The firm's response was inadequate, lacking evidence of systemic corrective action, procedure implementation, or training. 2. **Process Validation failures (21 CFR 820.75(a)):** The firm failed to validate the (b)(4) process used for (b)(4) wheelchair and hospital bed metal frames, despite its own procedure requiring it. The response was inadequate, providing no validation reports or analysis of other special processes, nor evidence of implementation or training. 3. **Design Control