FDA Inspection 816309 — Chr-Hansen - Wausau
The FDA completed an inspection of Chr-Hansen - Wausau on January 25, 2013 in Wausau, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 25, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wausau, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15836 | 21 CFR 111.70(c)(3) | QC specification, identity, purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |