FDA WARNING_LETTER - Mectronic Medicale S.R.L. - February 27, 2025

**FDA Warning Letter Summary**

**Company:** Via Orio Al Serio 15, Bergamo, Italy **Inspection Dates:** February 24-27, 2025 **Main Violations/Issues:** The FDA inspection identified significant non-compliance with the Quality System Regulation (QSR) under 21 CFR Part 820, resulting in the devices being deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. Key violations include:

1. **Design History Files (DHF):** The firm failed to adequately document design control elements for their therapeutic devices, as required by 21 CFR 820.30(j).

2. **Process Validation:** The company did not validate processes where results cannot be fully verified, violating 21 CFR 820.75(a). This includes a lack of validation for the output calibration system used in device production.

3. **Nonconforming Product Control:** The firm did not properly identify and segregate nonconforming products, failing to comply with 21 CFR 820.90.

4. **Acceptance Activities:** There were no established procedures for receiving inspections, and critical component verification was inadequately documented, violating 21 CFR 820.80.

5. **Complaint Handling:** The firm lacked documented procedures for complaint evaluation, as required by 21 CFR 820.198(a).

6. **Servicing Procedures:** The company did not have specific procedures for servicing activities, documentation, and acceptance testing, violating 21 CFR 820.200.

7. **Training Procedures:** The firm failed to maintain training records and plans for employees, violating 21 CFR 820.25(b).

8. **Device History Records:** The company did not maintain complete device history records, as required by 21 CFR 820.184.

**Regulatory Framework:** Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 321(h), 351(h), 360hh(2);