FDA Inspection
Spirus Medical, LLCSpirus Medical, LLC – FDA Inspection, Feb 8, 2012
Record Details
This FDA Inspection record concerns Spirus Medical, LLC, with an inspection on February 8, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spirus Medical, LLC
- Inspection Date
- February 8, 2012
- Product Type
- Devices
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ID · 69baa9d9-5bac-4ff6-b61a-07bf0fe91d06
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766719
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spirus Medical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 6, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spirus Medical, LLC
- FDA Inspection 1190817 - 2022-11-18
- FDA Inspection 1055653 - 2018-06-06
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