FDA Inspection
NEXALIN TECHNOLOGY INC.NEXALIN TECHNOLOGY INC. – FDA Inspection, Mar 10, 2023
Record Details
This FDA Inspection record concerns NEXALIN TECHNOLOGY INC., with an inspection on March 10, 2023, issued by the Dallas District Office.
- Company
- NEXALIN TECHNOLOGY INC.
- Inspection Date
- March 10, 2023
View Company Profile
ID · 8cb6d213-fdc6-4422-8bfb-485d0a9ec2de
Inspection Facts
- Inspection number
- 1199414
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of NEXALIN TECHNOLOGY INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for NEXALIN TECHNOLOGY INC.
- FDA Inspection 1118298 - 2020-02-20
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