FDA Inspection
Elegant Direct CorpElegant Direct Corp – FDA Inspection, Nov 10, 2021
Record Details
This FDA Inspection record concerns Elegant Direct Corp, with an inspection on November 10, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elegant Direct Corp
- Inspection Date
- November 10, 2021
- Product Type
- Devices
View Company Profile
ID · 250fd594-f8da-4a9f-aa3d-f0de34ecff65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1156379
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
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
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elegant Direct Corp
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elegant Direct Corp
- FDA Inspection 1261687 - 2024-12-02
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