FDA Inspection
F Care Systems USA, LLCF Care Systems USA, LLC – FDA Inspection, Mar 6, 2017
Record Details
This FDA Inspection record concerns F Care Systems USA, LLC, with an inspection on March 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8caacd9b-e965-411d-af73-e5dc59d9cce3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006384
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint 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 |
| December 5, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 30, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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