FDA Inspection
Sunshine USA, LLCSunshine USA, LLC – FDA Inspection, Aug 17, 2023
Record Details
This FDA Inspection record concerns Sunshine USA, LLC, with an inspection on August 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fe2b561e-5d02-4280-9653-a29d5fbb2366
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1215779
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Sunshine USA, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2025 | VAI | New Orleans District Office | Compliance: Medical 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 1268194 - 2025-04-28
- FDA Inspection 948861 - 2015-11-19
- FDA Inspection 837378 - 2013-06-14
- FDA Inspection 765527 - 2012-01-25
- FDA Inspection 733202 - 2011-03-04
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