FDA Inspection
Z Spine & Orthopaedics LLCZ Spine & Orthopaedics LLC – FDA Inspection, Mar 13, 2013
Record Details
This FDA Inspection record concerns Z Spine & Orthopaedics LLC, with an inspection on March 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Z Spine & Orthopaedics LLC
- Inspection Date
- March 13, 2013
- Product Type
- Devices
View Company Profile
ID · e786c71e-4dae-4da5-8777-23ccc4ac6dd6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 822175
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.