FDA Inspection
FCC Horiuchi Co., Ltd.FCC Horiuchi Co., Ltd. – FDA Inspection, May 17, 2024
Record Details
This FDA Inspection record concerns FCC Horiuchi Co., Ltd., with an inspection on May 17, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 40a2dbdb-01af-4e0c-891b-4ccd00ae770b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1238999
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
10- 21 CFR 114.80(b)Code - required elements
- 21 CFR 108.25(f)Approved school
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 108.25(c)(3)(i)Process adherence
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.105(i)QC - required operations master manufacturing/batch records
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