FDA Inspection
Makai Fruits LLCFDA Inspection 1279650 - Makai Fruits LLC - August 27, 2025
Record Details
This FDA Inspection record concerns Makai Fruits LLC, with an inspection on August 27, 2025, issued by the Dallas District Office, covering foods & cosmetics.
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ID · 59ef9f71-0c5d-41b9-8e53-d601c0ebdd27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1279650
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.506(d)(1)(i)Verification activity assurance
- 21 CFR 1.504(d)Document review entity"s hazard analysis
- 21 CFR 1.506(b)Supplier verification - establish written procedures
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.504(a)Hazard analysis written
- 21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
- 21 CFR 1.504(d)Document review entity's hazard analysis
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