FDA Inspection
Valorem Surgical LLCFDA Inspection 1001452 - Valorem Surgical LLC - October 26, 2016
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.
Record Details
This FDA Inspection record concerns Valorem Surgical LLC, with an inspection on October 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 54b11fab-8fc0-4086-a2d4-aedc7f1185f6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1001452
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.180Availability
- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Valorem Surgical LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 26, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |