FDA Inspection
Weinert Fiber Optics Inc.Weinert Fiber Optics Inc. – FDA Inspection, Aug 10, 2016
Record Details
This FDA Inspection record concerns Weinert Fiber Optics Inc., with an inspection on August 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Weinert Fiber Optics Inc.
- Inspection Date
- August 10, 2016
- Product Type
- Devices
View Company Profile
ID · b4546e9a-81bb-4b08-996e-488bc55753c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980868
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Weinert Fiber Optics Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 21, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Weinert Fiber Optics Inc.
- FDA Inspection 1195236 - 2023-01-13
- FDA Inspection 1074745 - 2018-11-21
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