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FDA Inspection
•VITANG TECHNOLOGY LLC•January 31, 2023

VITANG TECHNOLOGY LLC – FDA Inspection, Jan 31, 2023

Record Details

This FDA Inspection record concerns VITANG TECHNOLOGY LLC, with an inspection on January 31, 2023, issued by the Los Angeles District Office.

Company
VITANG TECHNOLOGY LLC
Inspection Date
January 31, 2023
Office
Los Angeles District Office
Person
  • Alexandria L. Capuano (Investigator)
View Company Profile

ID · 99c06ced-5d6d-400d-9b76-ab396be888fd

Inspection Facts

Inspection number
1196110
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

13
  1. 21 CFR 820.184DHR content
  2. 21 CFR 820.184(f)DHR - UDI not included
  3. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  4. 21 CFR 820.20(c)Management review dates
  5. 21 CFR 820.22Quality Audit/Reaudit - conducted
  6. 21 CFR 820.25(b)Training records
  7. 21 CFR 820.30(j)Design history file
  8. 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
  9. 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
  10. 21 CFR 820.70(i)Software validation for automated processes

Showing 10 of 13 citations.

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Other FDA inspections of VITANG TECHNOLOGY LLC

2
DateClassificationOfficeProject area
September 10, 2026Not classifiedLos Angeles District Office
December 8, 2023Not classifiedLos Angeles District Office
Other documents for VITANG TECHNOLOGY LLC
  • FDA Inspection 1342694 - 2026-09-10
  • FDA Inspection 1225436 - 2023-12-08

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