FDA Inspection
Sunshine USA, LLCSunshine USA, LLC – FDA Inspection, Jan 25, 2012
Record Details
This FDA Inspection record concerns Sunshine USA, LLC, with an inspection on January 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunshine USA, LLC
- Inspection Date
- January 25, 2012
- Product Type
- Devices
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ID · b2d494f5-b701-48de-bec7-90d43c21a37e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 765527
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
4- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 1002.13Failure to submit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sunshine USA, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2025 | VAI | New Orleans District Office | Compliance: Medical Devices |
| 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 |
| 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 1215779 - 2023-08-17
- FDA Inspection 948861 - 2015-11-19
- FDA Inspection 837378 - 2013-06-14
- FDA Inspection 733202 - 2011-03-04
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