FDA Inspection 1023105 — Aetherea, LLC
The FDA completed an inspection of Aetherea, LLC on August 25, 2017 in Verona, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 25, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Verona, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15391 | 21 CFR 111.10(b)(3) | Hand washing |
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16039 | 21 CFR 111.605(c) | Records - electronic |