FDA Inspection
Precision Spine IncPrecision Spine Inc – FDA Inspection, Feb 1, 2011
Record Details
This FDA Inspection record concerns Precision Spine Inc, with an inspection on February 1, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Precision Spine Inc
- Inspection Date
- February 1, 2011
- Product Type
- Biologics
View Company Profile
ID · a6fbafd6-ea4e-45de-84f0-d5f67cca6bf0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709036
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Precision Spine Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 18, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Precision Spine Inc
- FDA Inspection 1042884 - 2017-08-11
- FDA Inspection 919231 - 2015-03-18
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