FDA Inspection
Kelyniam Global, Inc.Kelyniam Global, Inc. – FDA Inspection, May 30, 2017
Record Details
This FDA Inspection record concerns Kelyniam Global, Inc., with an inspection on May 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cfc7c327-117c-47b7-8257-cb3bf6ca6f62
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1011997
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184DHR content
- 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 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 |
| April 17, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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