FDA Inspection
Weinert Fiber Optics Inc.Weinert Fiber Optics Inc. – FDA Inspection, Jan 13, 2023
Record Details
This FDA Inspection record concerns Weinert Fiber Optics Inc., with an inspection on January 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3a77d1df-1690-4f55-aead-2c6025840e96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195236
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Weinert Fiber Optics Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 10, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Weinert Fiber Optics Inc.
- FDA Inspection 1074745 - 2018-11-21
- FDA Inspection 980868 - 2016-08-10
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