Rossmax International Ltd. – FDA Warning Letter, Nov 1, 2007

This FDA Warning Letter, issued to Rossmax International Ltd. (Rossmax Taiwan and Rossmax China) on October 22, 2007, through November 1, 2007, identifies significant violations of the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820) for blood pressure monitors, which are classified as medical devices.

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate processes with objective acceptance criteria and specified machine parameters. The firm's response was inadequate, lacking documentation of corrective actions, implementation evidence, and a preventive action plan. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100):** Inadequate CAPA procedures, evidenced by insufficient investigations into returned products and missing instruction manuals. The revised procedure did not address how email information is integrated into CAPA reports. 3. **Nonconforming Product (21 CFR 820.90(a)):** Failure to establish and maintain adequate procedures for nonconforming product, specifically regarding products processed outside specifications but not identified as nonconforming. 4. **Production Process Controls (21 CFR 820.70(a)):** Failure to develop, conduct, control, and monitor production processes to ensure device conformity