FDA Inspection
SunMed Holdings, LLCSunMed Holdings, LLC – FDA Inspection, Jun 13, 2011
Record Details
This FDA Inspection record concerns SunMed Holdings, LLC, with an inspection on June 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SunMed Holdings, LLC
- Inspection Date
- June 13, 2011
- Product Type
- Devices
View Company Profile
ID · bd605eea-4aef-4a78-a950-b6d978a97c02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 728469
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.20(b)(3)Events
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
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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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