FDA Inspection 765527 — Sunshine USA, LLC
The FDA completed an inspection of Sunshine USA, LLC on January 25, 2012 in Johnson City, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 25, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Johnson City, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 5005 | 21 CFR 1002.11 | Failure to submit |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |