FDA Inspection
VITANG TECHNOLOGY LLCVITANG TECHNOLOGY LLC – FDA Inspection, Dec 8, 2023
Record Details
This FDA Inspection record concerns VITANG TECHNOLOGY LLC, with an inspection on December 8, 2023, issued by the Los Angeles District Office.
- Company
- VITANG TECHNOLOGY LLC
- Inspection Date
- December 8, 2023
View Company Profile
ID · d02a765e-3e69-460d-81fe-cd437044cbb6
Inspection Facts
- Inspection number
- 1225436
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.70(i)Software validation for automated processes
Showing 10 of 11 citations.
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Other FDA inspections of VITANG TECHNOLOGY LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2026 | Not classified | Los Angeles District Office | |
| January 31, 2023 | Not classified | Los Angeles District Office | Compliance: Devices |
Other documents for VITANG TECHNOLOGY LLC
- FDA Inspection 1342694 - 2026-09-10
- FDA Inspection 1196110 - 2023-01-31
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