FDA Inspection 1136458 — Atofil LLC
The FDA completed an inspection of Atofil LLC on Mar 10, 2021 in Cape Coral, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 10, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Cape Coral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15561 | 21 CFR 111.260(k)(3) | Batch record - tests, examinations; results |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15847 | 21 CFR 111.73 | Specifications met - component identity |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |