FDA Inspection
Panther James LLC. dba DroughtPanther James LLC. dba Drought – FDA Inspection, Aug 31, 2018
Record Details
This FDA Inspection record concerns Panther James LLC. dba Drought, with an inspection on August 31, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 0dc16060-9d1e-45bd-8a3f-743d81c1df09
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1064053
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 120.10(a)Corrective action - predetermined plan
- 21 CFR 120.11(b)Validation - reviewer's qualifications
- 21 CFR 120.12(c)Records - signed/dated
- 21 CFR 120.6(b)Sanitation monitoring
- 21 CFR 120.8(a)HACCP plan not implemented
- 21 CFR 120.8(a)No HACCP plan
- 21 CFR 120.8(b)(2)HACCP plan - critical control points not listed
- 21 CFR 120.8(b)(3)HACCP plan - critical limits not listed or not adequate
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Other FDA inspections of Panther James LLC. dba Drought
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 29, 2021 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 2, 2020 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 9, 2020 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| January 20, 2017 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Panther James LLC. dba Drought
- FDA Inspection 1181636 - 2022-10-12
- FDA Inspection 1147357 - 2021-07-29
- FDA Inspection 1132890 - 2020-11-02
- FDA Inspection 1120126 - 2020-03-09
- FDA Inspection 998551 - 2017-01-20
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