Epimed International, Inc. – FDA Warning Letter, May 17, 2012

On September 19, 2012, the FDA issued a Warning Letter to Epimed International, Inc. following an inspection from May 1-17, 2012, at their Johnstown, NY facility. The inspection revealed that the firm's R-F Thermocouple Electrode and R-F Cannula devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Incoming Product Acceptance (21 CFR 820.80(b))**: Failure to establish and maintain procedures for incoming product acceptance, including testing without original manufacturing specifications and accepting non-conforming lots without proper documentation. 2. **Complaint Handling (21 CFR 820.198(a))**: Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints. This included not contacting the original supplier for malfunction investigations, lacking documentation for "extensive investigations," and using inconsistent test methods for returned devices. 3. **Purchasing Controls (21 CFR 820.50)**: Failure to ensure purchased products and services conform to requirements, specifically lacking agreements with supplier (b)(4) defining responsibilities and failing to maintain a supplier file. 4. **Design Control (21 CFR 82