Doro, Inc. – FDA Warning Letter, Nov 13, 2014

On March 9, 2015, the FDA issued a Warning Letter to Doro, Inc. following an inspection from November 10-13, 2014, which found their wheeled stretchers, classified as medical devices, to be adulterated. The inspection revealed non-conformity with Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Deficiencies in analyzing quality data, verifying effectiveness, disseminating information, management review, and documentation. Doro's revised procedure was inadequate, lacking requirements for analyzing potential nonconformances, and training records were not provided. 2. **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: No established procedures or complete design history files for Evacu-B stretchers, missing records for design inputs/outputs, verification, validation, and reviews. The revised procedure was inadequate regarding planning and addressing design input requirements. 3. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: Procedure lacked requirements for receipt, review, evaluation, and investigation of complaints, including documenting device failure and