FDA WARNING_LETTER - ONBO Electronics Company Ltd - March 13, 2008

On March 10-13, 2008, the FDA inspected ONBO Electronics Company Ltd. in Shenzhen, China, a manufacturer of digital blood pressure monitors and digital thermometers. The inspection found these devices adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **CAPA Process Deficiencies (21 CFR 820.100(a)(6)):** Failure to disseminate quality problem information, lacking written procedures with Microlife USA for complaint reporting, trending, and CAPA data sharing. Responses were inadequate as device history records are at ONBO, and quarterly reviews are insufficient. 2. **Rework Procedures (21 CFR 820.90(b)(2)):** Absence of established rework procedures, retesting, and reevaluation for nonconforming products, specifically for circuit board rework. Responses were inadequate, lacking clear instructions on rework limits and scientific evidence of no adverse effects. 3. **Process Validation (21 CFR 820.75(a)):** Lack of written validation protocols for plastic injection molding, inadequate assessment of calibration parameters for installation qualification, and insufficient documentation of operating parameters and validation data. Responses were inadequate, with information