FDA Inspection 998551 — Panther James LLC. dba Drought
The FDA completed an inspection of Panther James LLC. dba Drought on January 20, 2017 in Clinton Township, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 20, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Clinton Township, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12743 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures not adequate |
| 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 |
| 12748 | 21 CFR 120.8(b)(5) | HACCP plan - corrective action plan not included |
| 9929 | 21 CFR 120.12(b)(4) | Records - information not entered when observed |
| 9932 | 21 CFR 120.6(a) | Sanitation SSOP - none or not implemented |
| 9935 | 21 CFR 120.7(a) | No hazard analysis |
| 9941 | 21 CFR 120.8(a) | No HACCP plan |
| 9943 | 21 CFR 120.8(a) | HACCP plan - location and type of juice |
| 9947 | 21 CFR 120.11(b) | HACCP plan - not validated |
| 9986 | 21 CFR 120.24(c) | Process controls - not exempt, single facility |