NEXALIN TECHNOLOGY INC. – FDA 483, Feb 20, 2020
NEXALIN TECHNOLOGY INC. in Houston, TX, a specification developer for a Class 3 transcranial electrotherapy stimulator (TESA), was inspected and found to have significant quality system deficiencies. The firm failed to maintain a device master record, establish adequate design control procedures, and properly document or implement corrective and preventive actions. Additionally, procedures for handling and evaluating customer complaints were not established, indicating a broad lack of adherence to quality system requirements.
- Office
- Dallas District Office
- Person
ID · 002bfd95-6ad3-4a2a-ba11-26867aba45d9
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