FDA WARNING_LETTER - Enraf-Nonius B.V. - March 27, 2013

On March 25-27, 2013, an FDA inspection of Enraf-Nonius B.V. in Rotterdam, Netherlands, revealed that their motorized tables, ultrasound therapy, and diathermy devices are adulterated under Section 501(h) of the Act. The firm's manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to control device design (21 CFR 820.30(a))**: Examples include not establishing acceptance criteria for Sonopuls 190 clinical validation, failing to determine if design changes require validation/verification, and lacking documentation for post-production design verification and specific test methods/acceptance criteria for various design verification activities. 2. **Failure to ensure suitability of inspection, measuring, and test equipment (21 CFR 820.72(a))**: The design verification procedure does not require full validation of test equipment and software prior to use. 3. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure lacks a process to ensure corrective actions prevent reoccurrence and is only used for internal/external audit issues. 4. **Failure to document CAPA investigation activities (21 CFR 820.1