FDA Inspection
Pure TropicPure Tropic – FDA Inspection, Aug 14, 2024
Record Details
This FDA Inspection record concerns Pure Tropic, with an inspection on August 14, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · f13f0094-7bf9-4b03-9672-7f9465390ca6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1246527
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
FDA Citations
9- 21 CFR 113.40(g)(1)(i)(B)Present each sterilizer, accurate
- 21 CFR 117.80(a)(2)Appropriate quality control operations
- 21 CFR 113.87(a)Operating processes not posted
- 21 CFR 113.40(g)(1)(i)(A)(4)Aseptic processing: TID not accurate to 1° F
- 21 CFR 113.40(g)(2)(i)(A)Recording device - flow rate, temperature, concentration
- 21 CFR 113.40(g)(1)(i)(A)No accurate TID
- 21 CFR 113.40(g)(1)(i)(F)Unauthorized flow adjustments
- 21 CFR 113.10Supervisors
- 21 CFR 113.40(g)(1)(i)(A)(4)Aseptic processing: TID not accurate to 1� F
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Other FDA inspections of Pure Tropic
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2015 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Pure Tropic
- FDA Inspection 925291 - 2015-04-30
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