FDA Inspection
SI-BONE, Inc.SI-BONE, Inc. – FDA Inspection, May 20, 2014
Record Details
This FDA Inspection record concerns SI-BONE, Inc., with an inspection on May 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SI-BONE, Inc.
- Inspection Date
- May 20, 2014
- Product Type
- Devices
View Company Profile
ID · 9a7cff76-e708-44e3-9f71-8f7a0c33f6d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 880126
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of SI-BONE, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 6, 2016 | Not classified | San Francisco District Office |
Other documents for SI-BONE, Inc.
- FDA Inspection 1167317 - 2022-03-31
- FDA Inspection 998766 - 2016-12-06
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