FDA Inspection
Southern Spine, LLCSouthern Spine, LLC – FDA Inspection, Mar 24, 2011
Record Details
This FDA Inspection record concerns Southern Spine, LLC, with an inspection on March 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Southern Spine, LLC
- Inspection Date
- March 24, 2011
- Product Type
- Devices
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ID · df55ab2b-cbb7-4823-ae4f-b7781673c864
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 732286
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- Medical Device Field Exam
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Southern Spine, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 18, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 29, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 24, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Southern Spine, LLC
- FDA Inspection 1122829 - 2020-01-13
- FDA Inspection 1051154 - 2018-04-18
- FDA Inspection 928354 - 2015-04-29
- FDA Inspection 850599 - 2013-09-24
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