FDA Inspection
SunMed Holdings, LLCSunMed Holdings, LLC – FDA Inspection, Feb 9, 2010
Record Details
This FDA Inspection record concerns SunMed Holdings, LLC, with an inspection on February 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SunMed Holdings, LLC
- Inspection Date
- February 9, 2010
- Product Type
- Devices
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ID · e13ccaa1-52f1-4166-b858-71b85564fa8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 644143
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(b)Procedures
Full citation text and observation details available on the Dashboard.
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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