FDA Inspection 1102052 — ADT/AROMAS DEL TUNGURAHUA
The FDA completed an inspection of ADT/AROMAS DEL TUNGURAHUA on September 10, 2019 in Ambato. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 10, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ambato (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |