FDA Inspection 1216068 — CT Health Solutions, LLC
The FDA completed an inspection of CT Health Solutions, LLC on August 23, 2023 in Homosassa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Homosassa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |