FDA Inspection
Sunshine USA, LLCSunshine USA, LLC – FDA Inspection, Jun 14, 2013
Record Details
This FDA Inspection record concerns Sunshine USA, LLC, with an inspection on June 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunshine USA, LLC
- Inspection Date
- June 14, 2013
- Product Type
- Devices
View Company Profile
ID · 81deab01-8924-4352-a896-9fbe0bfc72d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 837378
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 1040.20(f)Test deficiencies
- 21 CFR 820.184DHR content
Showing 10 of 13 citations.
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 |
| 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 1215779 - 2023-08-17
- FDA Inspection 948861 - 2015-11-19
- 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.