FDA Inspection 775332 — Chr-Hansen - Wausau
The FDA completed an inspection of Chr-Hansen - Wausau on April 5, 2012 in Wausau, 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
- April 5, 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 |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15459 | 21 CFR 111.20(d) | Physical plant - design and construction |
| 15507 | 21 CFR 111.27(a)(5)(i) | Refrigerator, freezer - temperature recording device |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15850 | 21 CFR 111.73 | Specifications met in-process purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |