FDA Inspection 805296 — Krier Foods, LLC
The FDA completed an inspection of Krier Foods, LLC on November 14, 2012 in Random Lake, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 21 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 14, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Random Lake, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 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 |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |
| 1697 | 21 CFR 110.80(b)(4) | Preventive control measures |
| 9930 | 21 CFR 120.6(c) | SSOP records |
| 9961 | 21 CFR 120.24(a) | Process controls - HACCP plan - 5 log reduction |