FDA Inspection
KEOS LLCKEOS LLC – FDA Inspection, Aug 23, 2019
Record Details
This FDA Inspection record concerns KEOS LLC, with an inspection on August 23, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 72908851-263f-48e0-b0de-0a09d6feeefe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100408
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of KEOS LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for KEOS LLC
- FDA Inspection 1196580 - 2023-01-11
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