FDA Inspection
Integrity Spine LLCIntegrity Spine LLC – FDA Inspection, May 22, 2015
Record Details
This FDA Inspection record concerns Integrity Spine LLC, with an inspection on May 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Integrity Spine LLC
- Inspection Date
- May 22, 2015
- Product Type
- Devices
View Company Profile
ID · 8f7ba7bf-1fab-4ad7-be38-25c879d1ac2e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929448
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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