FDA Inspection
Meridian Medical Systems LLCMeridian Medical Systems LLC – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns Meridian Medical Systems LLC, with an inspection on February 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · bc128304-fb8d-4d13-9ca6-63426f41b954
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002415
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Meridian Medical Systems LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 31, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Meridian Medical Systems LLC
- FDA Inspection 878130 - 2014-05-15
- FDA Inspection 832897 - 2013-05-31
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.