FDA Inspection 852070 — Wyldewood Cellars Inc
The FDA completed an inspection of Wyldewood Cellars Inc on November 26, 2013 in Peck, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 26, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Peck, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15381 | 21 CFR 111.8 | Written procedures - hygienic practices |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15730 | 21 CFR 111.365(c) | Water - Federal, State, local requirements |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15835 | 21 CFR 111.70(c)(2) | Documentation specifications - contamination limits |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15946 | 21 CFR 111.105(i) | QC - required operations returned dietary supplements |
| 9930 | 21 CFR 120.6(c) | SSOP records |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9932 | 21 CFR 120.6(a) | Sanitation SSOP - none or not implemented |
| 9935 | 21 CFR 120.7(a) | No hazard analysis |
| 9939 | 21 CFR 120.7(c) | All hazards not considered |
| 9941 | 21 CFR 120.8(a) | No HACCP plan |
| 9961 | 21 CFR 120.24(a) | Process controls - HACCP plan - 5 log reduction |