FDA Inspection
EMSIEMSI – FDA Inspection, Sep 8, 2014
Record Details
This FDA Inspection record concerns EMSI, with an inspection on September 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EMSI
- Inspection Date
- September 8, 2014
- Product Type
- Devices
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ID · b091b147-caff-43bf-9adb-f9ca9a3d3a36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EMSI
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 15, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 27, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 24, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for EMSI
- FDA Inspection 1192319 - 2022-12-08
- FDA Inspection 1056142 - 2018-06-15
- FDA Inspection 774197 - 2012-03-27
- FDA Inspection 649429 - 2010-02-24
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