FDA Inspection
Fresenius U.S.A. ManufacturingFresenius U.S.A. Manufacturing – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns Fresenius U.S.A. Manufacturing, with an inspection on June 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d641c6c1-3e08-4451-a67c-5668a9114667
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016670
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Fresenius U.S.A. Manufacturing
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fresenius U.S.A. Manufacturing
- FDA Inspection 1206544 - 2023-05-08
- FDA Inspection 809863 - 2012-12-27
- FDA Inspection 667215 - 2010-06-15
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