FDA Inspection 837378 — Sunshine USA, LLC
The FDA completed an inspection of Sunshine USA, LLC on June 14, 2013 in Johnson City, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 14, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Johnson City, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 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 |
| 5244 | 21 CFR 1040.20(f) | Test deficiencies |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |