FDA Inspection 1099993 — Carotec Inc.
The FDA completed an inspection of Carotec Inc. on August 20, 2019 in Coral Gables, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 20, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Coral Gables, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15964 | 21 CFR 111.113(c) | Document - material review, disposition |