FDA Inspection
F Care Systems USA, LLCF Care Systems USA, LLC – FDA Inspection, Dec 5, 2012
Record Details
This FDA Inspection record concerns F Care Systems USA, LLC, with an inspection on December 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- F Care Systems USA, LLC
- Inspection Date
- December 5, 2012
- Product Type
- Devices
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ID · d840066f-3fa9-46e5-a8a9-eff17a9dbc15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816257
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of F Care Systems USA, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 21, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 6, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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