FDA Inspection
You First Services, Inc.You First Services, Inc. – FDA Inspection, Dec 18, 2023
Record Details
This FDA Inspection record concerns You First Services, Inc., with an inspection on December 18, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bff4e8fb-d7bc-4ea9-9584-66c7b3f32344
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1225717
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of You First Services, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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