FDA Inspection
Optimum Bioenergy International Corp.Optimum Bioenergy International Corp. – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Optimum Bioenergy International Corp., with an inspection on April 26, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 0361d1d7-a6f9-43fe-af6e-37dd7e552e30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087512
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 111.453Written procedures - holding
- 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(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.25(a)Procedures - calibrating instruments
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.16Written procedures - pest control
- 21 CFR 111.103Written procedures - quality control operations
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Other FDA inspections of Optimum Bioenergy International Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 16, 2017 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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