FDA Inspection
EMSIEMSI – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns EMSI, with an inspection on February 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EMSI
- Inspection Date
- February 24, 2010
- Product Type
- Devices
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ID · bfaa6c71-9b32-407c-90ea-2c9aabc858e6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 649429
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.198(e)(6)Results of investigation
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR 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 |
| 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 |
Other documents for EMSI
- FDA Inspection 1192319 - 2022-12-08
- FDA Inspection 1056142 - 2018-06-15
- FDA Inspection 893952 - 2014-09-08
- FDA Inspection 774197 - 2012-03-27
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