FDA Inspection
SpineSmith Holdings, LLCSpineSmith Holdings, LLC – FDA Inspection, Dec 9, 2008
Record Details
This FDA Inspection record concerns SpineSmith Holdings, LLC, with an inspection on December 9, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- SpineSmith Holdings, LLC
- Inspection Date
- December 9, 2008
- Product Type
- Biologics
View Company Profile
ID · 77649eee-bf15-4d9e-a73a-dfa70f4bb84c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 551227
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of SpineSmith Holdings, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Dallas District Office | Compliance: Medical Devices |
| August 1, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 9, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 29, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 6, 2017 | Not classified | Dallas District Office |
Other documents for SpineSmith Holdings, LLC
- FDA Inspection 1302634 - 2026-02-13
- FDA Inspection 1211189 - 2023-08-01
- FDA Inspection 1040452 - 2018-02-09
- FDA Inspection 1035321 - 2017-11-29
- FDA Inspection 1034245 - 2017-06-06
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