FDA Inspection 887380 — Atrium, Inc.
The FDA completed an inspection of Atrium, Inc. on July 17, 2014 in Wautoma, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 17, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wautoma, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 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 |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15981 | 21 CFR 111.123(a)(5) | Quality control operations - reprocessing |