FDA Inspection 1215779 — Sunshine USA, LLC
The FDA completed an inspection of Sunshine USA, LLC on August 17, 2023 in Johnson City, TN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 17, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Johnson City, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |