Guangdong Baihe Medical Technology Co., Ltd – FDA Warning Letter, Mar 30, 2012

On March 26-30, 2012, an FDA inspection of Guangdong Baihe Medical Technology Co., Ltd. in China, a manufacturer of hemodialysis and central venous catheters, revealed significant violations of the Quality System regulation (21 CFR Part 820). The devices were deemed adulterated under section 501(h) of the Act.

Key violations include: 1. **Failure to control process parameters (21 CFR 820.75(b)):** Inadequate monitoring of sterilization process parameters, specifically the lack of positive and negative controls in bioburden testing. The firm's response was insufficient, lacking a systemic corrective action plan and statistical rationale for limited retesting. 2. **Inadequate process validation (21 CFR 820.75(a)):** Bioburden testing incubation temperatures deviated from the specified standard, and documentation was lacking. The firm's response was inadequate, as it did not include a systemic review of other procedures using standards. 3. **Inadequate incoming product acceptance procedures (21 CFR 820.80(b)):** Incoming inspection records for certain components lacked evidence of required weight evaluations. The firm's response was deemed adequate for this point. 4. **Inadequate documentation of acceptance activities (21 CFR 820.80(e)):** * Lack of documentation for L