FDA Inspection 711809 — Chr-Hansen - Wausau
The FDA completed an inspection of Chr-Hansen - Wausau on February 17, 2011 in Wausau, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 17, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wausau, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15459 | 21 CFR 111.20(d) | Physical plant - design and construction |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15507 | 21 CFR 111.27(a)(5)(i) | Refrigerator, freezer - temperature recording device |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |