FDA Inspection
Pontis Orthopaedics, LLCPontis Orthopaedics, LLC – FDA Inspection, Jul 5, 2018
Record Details
This FDA Inspection record concerns Pontis Orthopaedics, LLC, with an inspection on July 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · a3074447-901b-443e-ba2e-9a2dae945c60
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1058009
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.180Availability
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pontis Orthopaedics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Pontis Orthopaedics, LLC
- FDA Inspection 891110 - 2014-08-22
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.