FDA Inspection
Ameri-Kal LLCFDA Inspection 1149302 - Ameri-Kal LLC - August 19, 2021
Record Details
This FDA Inspection record concerns Ameri-Kal LLC, with an inspection on August 19, 2021, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Ameri-Kal LLC
- Inspection Date
- August 19, 2021
- Product Type
- Food/cosmetics
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ID · e6ec4f8b-97a6-4209-9587-96a828bff5d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1149302
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
11- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.75(h)Tests, examinations - scientifically valid
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.605(b)Records - original, true copies
- 21 CFR 111.14(b)(2)Personnel - records - training
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.260(k)(2)Batch record - label
- 21 CFR 111.260(c)Batch record - date, time; maintenance
- 21 CFR 111.15(i)Hand-washing facilities
- 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield
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Other FDA inspections of Ameri-Kal LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2025 | NAI | Dallas District Office | Foodborne Biological Hazards |
| September 12, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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