FDA Inspection
SunMed Holdings, LLCSunMed Holdings, LLC – FDA Inspection, Jan 16, 2009
Record Details
This FDA Inspection record concerns SunMed Holdings, LLC, with an inspection on January 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SunMed Holdings, LLC
- Inspection Date
- January 16, 2009
- Product Type
- Devices
View Company Profile
ID · fa786553-93e1-4678-ac84-c939e2d6070f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 559238
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 806.10(d)Notification of extended action
- 21 CFR 820.198(e)(6)Results of investigation
- 21 CFR 803.40(a)Report of death, injury
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Other FDA inspections of SunMed Holdings, LLC
17| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 24, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SunMed Holdings, LLC
- FDA Inspection 1217802 - 2023-08-30
- FDA Inspection 1062683 - 2018-07-11
- FDA Inspection 977549 - 2016-06-24
- FDA Inspection 961621 - 2016-03-02
- FDA Inspection 938637 - 2015-08-04
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