FDA Inspection
Kelyniam Global, Inc.Kelyniam Global, Inc. – FDA Inspection, Apr 17, 2013
Record Details
This FDA Inspection record concerns Kelyniam Global, Inc., with an inspection on April 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kelyniam Global, Inc.
- Inspection Date
- April 17, 2013
- Product Type
- Devices
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ID · 82aa1178-5d7b-4520-8ae2-70d67764c82c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831319
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Kelyniam Global, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 22, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 15, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 30, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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