FDA Inspection
Cogent Technology, Ltd.Cogent Technology, Ltd. – FDA Inspection, Feb 14, 2019
Record Details
This FDA Inspection record concerns Cogent Technology, Ltd., with an inspection on February 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8e95bb9-44ae-49e8-a6c7-2d7bbef809e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079221
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cogent Technology, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cogent Technology, Ltd.
- FDA Inspection 1002324 - 2017-02-08
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