FDA Inspection
Blue OrthoBlue Ortho – FDA Inspection, Dec 17, 2015
Record Details
This FDA Inspection record concerns Blue Ortho, with an inspection on December 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Blue Ortho
- Inspection Date
- December 17, 2015
- Product Type
- Devices
View Company Profile
ID · 7e8d4b32-4d60-4ccb-ac6c-e01293663c0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 952969
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(e)Design review - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Blue Ortho
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Blue Ortho
- FDA Inspection 1239273 - 2024-04-11
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