FDA Inspection
Fujikura Fiber Optics Vietnam LtdFujikura Fiber Optics Vietnam Ltd – FDA Inspection, Jan 13, 2023
Record Details
This FDA Inspection record concerns Fujikura Fiber Optics Vietnam Ltd, with an inspection on January 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a7a2121a-d5f5-4778-b0d0-7fea620750dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195247
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.184DHR content
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Fujikura Fiber Optics Vietnam Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fujikura Fiber Optics Vietnam Ltd
- FDA Inspection 1009127 - 2017-03-02
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