FDA Inspection
Western Innovations, Inc.Western Innovations, Inc. – FDA Inspection, Feb 21, 2024
Record Details
This FDA Inspection record concerns Western Innovations, Inc., with an inspection on February 21, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 0734bd22-48b0-4171-8fc4-d6bfc6bebab1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1230626
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Enforcement
- Warning Letter
FDA Citations
10- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.10(b)Personnel - hygienic practices
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Other FDA inspections of Western Innovations, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2025 | VAI | Denver District Office | Food Composition, Standards, Labeling, and Economics |
| October 12, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Western Innovations, Inc.
- FDA Inspection 1268397 - 2025-04-30
- FDA Inspection 1070992 - 2018-10-12
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