FDA WARNING_LETTER - Don Tray Industries, Ltd - February 21, 2008

On February 19-21, 2008, an FDA inspection of Don Tay Industries, Ltd. in New Berlin, Wisconsin, revealed that the firm's electrocardiography (ECG) electrodes are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820.

Key violations include: 1. **Failure to maintain a design history file (21 CFR 820.30(j))**: Specifically, for the Softy Trode series, there was no documentation for design inputs (820.30(c)), outputs (820.30(d)), verification (820.30(f)), validation or risk analysis (820.30(g)). Design changes also lacked documented verification and validation before implementation (820.30(i)). 2. **Failure to have a complete device master record (21 CFR 820.181)**: The device master record for the Softy Trode series lacked specifications for the non-woven fabric component, references to testing/acceptance activities, or master copies of labeling. 3. **Failure to maintain a device history record (21 CFR 820.184)**: The firm was not following