Electro-Cap International, Inc. – FDA Warning Letter, Apr 28, 2011

On April 18-28, 2011, an FDA inspection of Electro-Cap International, Inc. in Eaton, OH, found that their Electro-Cap and Electro-Gel products, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain design change procedures (21 CFR 820.30(i))**: The firm did not validate or document changes to Electro-Gel's ingredients (e.g., switching from (b)(4) to (b)(4) and (b)(4), or replacing (b)(4) with (b)(4)), relying on undocumented literature research or customer feedback. Viscosity changes were made with a handwritten procedure and no specifications. Component changes for Electro-Cap (electrodes, connectors, wire ties) lacked validation and risk assessment. The firm's May 18, 2011, response was inadequate, as change documents lacked evaluation data and systemic corrective actions were not documented. 2. **Failure to establish and maintain adequate finished device acceptance procedures (21 CFR 820.80(d))**: Electro-Gel conductivity testing ceased in March 2011, and no procedure was available. There