FDA Inspection 1218765 — El Sol Brands, Inc.
The FDA completed an inspection of El Sol Brands, Inc. on September 26, 2023 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Miami, FL (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18283 | 21 CFR 1.505(b) | Supplier approval - document |
| 18286 | 21 CFR 1.505(c)(2) | Reevaluate - 3 years |
| 18295 | 21 CFR 1.506(d)(1)(i) | Verification activity assurance |
| 18303 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |
| 18331 | 21 CFR 1.510(a)(2) | Record - sign, date |
| 18334 | 21 CFR 1.510(b)(1) | Record - translate to English |