FDA Inspection
Mineral BioSciences, LLC.Mineral BioSciences, LLC. – FDA Inspection, Nov 24, 2025
Record Details
This FDA Inspection record concerns Mineral BioSciences, LLC., with an inspection on November 24, 2025, issued by the Denver District Office, covering foods & cosmetics.
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ID · 72eca86b-de13-4272-8198-3347d60bde26
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1292804
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.103Written procedures - follow; quality control operations
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.83(b)Reserve sample - container-closure system
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