FDA Inspection
Titan Spine, LLCTitan Spine, LLC – FDA Inspection, Dec 11, 2017
Record Details
This FDA Inspection record concerns Titan Spine, LLC, with an inspection on December 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a42482aa-1325-4c64-9204-f1908be2d78e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034589
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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