FDA Inspection 829954 — Atrium, Inc.
The FDA completed an inspection of Atrium, Inc. on May 20, 2013 in Wautoma, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 20, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wautoma, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15459 | 21 CFR 111.20(d) | Physical plant - design and construction |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15808 | 21 CFR 111.570(a) | Records - product complaints: readily available |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 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 |