FDA Inspection 1246463 — FX Chocolate
The FDA completed an inspection of FX Chocolate on Aug 15, 2024 in Daytona Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 15, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Daytona Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15524 | 21 CFR 111.30(a) | Equipment - automated - design, selection |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15940 | 21 CFR 111.105(h) | Quality control - production, process control |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22863 | 21 CFR 111.110 | Quality control - Laboratory control processes; production, process control |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |