Eidosmed – FDA Warning Letter, Oct 21, 2010

On October 6-21, 2010, an FDA inspection of Eidosmed, initial importer and distributor of the Electronic Depth Gauge (EDG 4.0) device, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under Section 501(h) of the Act. Eidosmed voluntarily destroyed all 783 devices on January 25, 2011.

The FDA found Eidosmed failed to: 1. **Establish and maintain design control procedures (21 CFR 820.30(a))**: No evidence of design control procedures applied to EDG 4.0. 2. **Validate device design (21 CFR 820.30(g))**: No shelf-life studies to support the "at least one year" design requirement or the three-year expiration date on labeling. 3. **Maintain a design history file (DHF) (21 CFR 820.30(j))**: Lacked formal design reviews, validation/verification of design changes, and results of design validation. 4. **Establish purchasing control procedures (21 CFR 820.50)**: No procedures for purchased products/services or quality system requirements for contract manufacturers. 5. **Conduct labeling inspection (21 CFR 820.