FDA Inspection
Meridian Medical Systems LLCMeridian Medical Systems LLC – FDA Inspection, May 31, 2013
Record Details
This FDA Inspection record concerns Meridian Medical Systems LLC, with an inspection on May 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Meridian Medical Systems LLC
- Inspection Date
- May 31, 2013
- Product Type
- Devices
View Company Profile
ID · ceee3a8d-d968-4318-ae1d-178984888f3b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 832897
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Meridian Medical Systems LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Meridian Medical Systems LLC
- FDA Inspection 1002415 - 2017-02-24
- FDA Inspection 878130 - 2014-05-15
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