FDA Inspection
Wooltari USA, INCWooltari USA, INC – FDA Inspection, Jul 28, 2023
Record Details
This FDA Inspection record concerns Wooltari USA, INC, with an inspection on July 28, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 86e3d1ab-6f8c-4584-aea6-5524edb7729c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1211084
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1.506(e)(1)(i)(B)Audit - food safety regulation, plan
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
- 21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.506(e)(1)(i)(B)Audit - food safety regulation, plan
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Other FDA inspections of Wooltari USA, INC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2025 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| October 25, 2022 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Wooltari USA, INC
- FDA Inspection 1267491 - 2025-03-19
- FDA Inspection 1182036 - 2022-10-25
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