FDA Inspection
Ibitta Enterprises, Inc.Ibitta Enterprises, Inc. – FDA Inspection, May 21, 2019
Record Details
This FDA Inspection record concerns Ibitta Enterprises, Inc., with an inspection on May 21, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · eb9c5486-e8c9-4132-ba01-e23e6072f9e8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1090650
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
11- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 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 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality
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Other FDA inspections of Ibitta Enterprises, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 4, 2021 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 29, 2016 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Ibitta Enterprises, Inc.
- FDA Inspection 1144121 - 2021-06-04
- FDA Inspection 975134 - 2016-06-29
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