FDA WARNING_LETTER - Electro Medical, Inc. - April 19, 2013

On April 15-19, 2013, an FDA inspection of Electro Medical Inc. in Tulsa, Oklahoma, revealed that the firm's Stim Flex 400, 400A, 150, and 500 devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's April 30, 2013, response to the FDA 483 was deemed inadequate.

Violations include: 1. **Failure to establish design control procedures (21 CFR 820.30(a))**: No documented design inputs, outputs, verification, validation, changes, or history files for Stim Flex 150 and 500. Response lacked corrective actions for missing documentation and failed to adequately address risk analysis for Stim Flex 150's technological differences. 2. **Inadequate acceptance activity procedures (21 CFR 820.80(a))**: In-process inspection records were discarded, and no acceptance records for 7 Stim Flex 400A and approximately 40 Stim Flex 150 units were available. Response lacked timeframe and specific corrective actions. 3. **Failure to perform quality audits (21 CFR