FDA 483 - Electromedical Technologies, LLC - April 15, 2025
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Electromedical Technologies, Inc. in Scottsdale, AZ, was cited with eight observations during an FDA inspection from April 7-15, 2025. The firm demonstrated significant deficiencies across its quality system, including inadequate procedures for complaint handling, internal audits, supplier controls, CAPA, device master records, design changes, and device history records. Additionally, the firm failed to register its repackaged electrodes in the Global Unique Device Identification Database.
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ID · 3c6b8868-db03-4352-b7cb-45aab49080d8