FDA Inspection
Elmed IncorporatedElmed Incorporated – FDA Inspection, Jul 17, 2023
Record Details
This FDA Inspection record concerns Elmed Incorporated, with an inspection on July 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b4d5b5fb-7c05-4105-aec5-12be1dd95dc8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210243
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Elmed Incorporated
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 12, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 7, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 17, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elmed Incorporated
- FDA Inspection 1088027 - 2019-04-12
- FDA Inspection 986692 - 2016-09-21
- FDA Inspection 891957 - 2014-08-12
- FDA Inspection 712807 - 2011-03-07
- FDA Inspection 590843 - 2009-06-17
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