FDA Inspection
Koelis SASKoelis SAS – FDA Inspection, Jul 26, 2018
Record Details
This FDA Inspection record concerns Koelis SAS, with an inspection on July 26, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- James W. Whitney (Issuing Officer)
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ID · 982e1149-865f-45e9-9ce8-1d5dc285b604
Inspection Facts
- Inspection number
- 1060443
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Koelis SAS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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