FDA Inspection
American BioSciences, Inc.American BioSciences, Inc. – FDA Inspection, Aug 7, 2023
Record Details
This FDA Inspection record concerns American BioSciences, Inc., with an inspection on August 7, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 532ee99a-d3cc-4d07-a6a2-72cc0ece0f06
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1213031
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 111.170Quarantine component, package, labels, rejected product
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.140(a)Records - QC operations: originals, copies, electronic
- 21 CFR 111.140(a)Records - QC operations: originals, copies, electronic
- 21 CFR 111.170Quarantine component, package, labels, rejected product
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
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Other FDA inspections of American BioSciences, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 25, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for American BioSciences, Inc.
- FDA Inspection 1096842 - 2019-07-11
- FDA Inspection 977672 - 2016-07-25
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