FDA Inspection
Gergens Orthodontic Lab, Inc.Gergens Orthodontic Lab, Inc. – FDA Inspection, Mar 30, 2023
Record Details
This FDA Inspection record concerns Gergens Orthodontic Lab, Inc., with an inspection on March 30, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · da8df3a8-5cad-4891-94ba-46646cfb4528
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1201361
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gergens Orthodontic Lab, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gergens Orthodontic Lab, Inc.
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.