FDA Inspection 1064053 — Panther James LLC.
The FDA completed an inspection of Panther James LLC. on Aug 31, 2018 in Clinton Township, MI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 31, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Clinton Township, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12732 | 21 CFR 120.10(a) | Corrective action - predetermined plan |
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12746 | 21 CFR 120.8(b)(2) | HACCP plan - critical control points not listed |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9941 | 21 CFR 120.8(a) | No HACCP plan |
| 9946 | 21 CFR 120.11(b) | Validation - reviewer's qualifications |
| 9958 | 21 CFR 120.12(c) | Records - signed/dated |