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 NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 10, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- 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 |