FDA Inspection
Herbal Science International, Inc.Herbal Science International, Inc. – FDA Inspection, Jun 3, 2019
Record Details
This FDA Inspection record concerns Herbal Science International, Inc., with an inspection on June 3, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · c4cfed25-17e1-4c93-bd92-08d2f9fd403f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1091660
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 111.25(a)Procedures - calibrating instruments
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.353Manufacturing operations - written procedures
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(c)(1)In-process identity, purity, strength, composition
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
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Other FDA inspections of Herbal Science International, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2016 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 25, 2012 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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