FDA Inspection 799002 — AMK Prescott, LLC
The FDA completed an inspection of AMK Prescott, LLC on August 18, 2012 in Prescott, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 18, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Prescott, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1125 | 21 CFR 110.40(a) | Materials and workmanship |
| 1552 | 21 CFR 110.35(a) | Buildings/sanitary |
| 1553 | 21 CFR 110.35(a) | Buildings/good repair |
| 1599 | 21 CFR 110.37(b)(5) | Backflow prevention |
| 3062 | 21 CFR 114.10 | Personnel |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3082 | 21 CFR 114.89 | Process deviation |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 3090 | 21 CFR 114.100(d) | Product distribution |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |