FDA Inspection
EMSIEMSI – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns EMSI, with an inspection on June 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7f2d2059-b439-4d14-a137-4ceea9239184
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1056142
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.30(i)Design changes - 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 |
| September 8, 2014 | VAI | Center for Devices and Radiological Health | Compliance: 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 893952 - 2014-09-08
- FDA Inspection 774197 - 2012-03-27
- FDA Inspection 649429 - 2010-02-24
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