FDA Inspection
Sunshine USA, LLCSunshine USA, LLC – FDA Inspection, Apr 28, 2025
Record Details
This FDA Inspection record concerns Sunshine USA, LLC, with an inspection on April 28, 2025, issued by the New Orleans District Office, covering medical devices & rad health.
View Company Profile
ID · ebba1e8b-a492-4af9-8614-af57eeadd53d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268194
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sunshine USA, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 25, 2012 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sunshine USA, LLC
- FDA Inspection 1215779 - 2023-08-17
- FDA Inspection 948861 - 2015-11-19
- FDA Inspection 837378 - 2013-06-14
- FDA Inspection 765527 - 2012-01-25
- FDA Inspection 733202 - 2011-03-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.