FDA Inspection 790832 — Chr-Hansen - Wausau
The FDA completed an inspection of Chr-Hansen - Wausau on July 13, 2012 in Wausau, 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
- July 13, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wausau, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15459 | 21 CFR 111.20(d) | Physical plant - design and construction |
| 15482 | 21 CFR 111.23(c) | Records - water |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15973 | 21 CFR 111.120(c) | Quality control operations - material review, disposition decision |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |