FDA WARNING_LETTER - Electromedical Products International, Inc. - February 01, 2013

On January 28, 2013, the FDA inspected Electromedical Products International, Inc. in Mineral Wells, Texas, and found that their Alpha-Stim M microcurrent and cranial stimulator (CES) devices were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing, packing, storage, or installation methods and controls did not conform to the Quality System regulation (21 CFR Part 820).

Violations included: 1. **Failure to control suppliers (21 CFR 820.50(a)(2)):** The firm's Quality Manual did not define "significant nonconforming product" to trigger supplier re-evaluation. Despite high nonconformances in three lots of Alpha-Stim M units from a contract manufacturer, no re-evaluation was performed. The firm's response was inadequate as it did not specify control for non-critical suppliers or how critical suppliers would be determined, nor did it adequately justify the lack of re-evaluation. 2. **Failure to establish corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** Three CAPAs (CAR-CCR-2012-ED05, CAR-CCR-2011-ED22, CAR-CCR-2011-ED02) were closed without evaluating their effectiveness