FDA WARNING_LETTER - Nissei Precision Instruments (Suzhou) Co., LTD - June 28, 2012

On June 25-28, 2012, an FDA inspection of Nissei Precision Instruments (Suzhou) Co., Ltd. in China, a manufacturer of the WSK-1011 wrist blood pressure monitor, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated. The firm's July 11, 2012, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Procedures lacked methods for analyzing quality data sources, addressing statistical methodologies for recurring problems, adequately implementing corrective actions (e.g., CAPA 2011-6 closed prematurely), and verifying/validating corrective actions (e.g., insufficient justification for validation sample size). 2. **Complaint Handling (21 CFR 820.198(a), (b)):** Procedures did not formally designate a unit for complaint review, require evaluation for Medical Device Reporting (MDR) (21 CFR Part 803), or mandate documentation for all complaints, including those deemed insignificant. 3. **Process Validation (21 CFR 820.75(a)):** Lack of validation for processes and equipment, with no documentation for specific equipment validation.