FDA Inspection
You First Services, Inc.You First Services, Inc. – FDA Inspection, Dec 20, 2019
Record Details
This FDA Inspection record concerns You First Services, Inc., with an inspection on December 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- You First Services, Inc.
- Inspection Date
- December 20, 2019
- Product Type
- Devices
View Company Profile
ID · 9b4a9c65-b8c5-4b86-b933-74597bbea605
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1114269
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of You First Services, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 21, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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