FDA Inspection
Cosmax Bio, Inc.Cosmax Bio, Inc. – FDA Inspection, Aug 30, 2024
Record Details
This FDA Inspection record concerns Cosmax Bio, Inc., with an inspection on August 30, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 4d73b479-d268-448e-b6dc-0a25c47be723
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1248502
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
13- 21 CFR 114.83Scheduled process establishment
- 21 CFR 114.80(b)Code - required elements
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 114.100(b)Maintenance of processing and production records
- 21 CFR 111.25(b)Make and keep records - laboratory operations
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.27(a)Equipment - design - appropriate and suitable
- 21 CFR 111.260Batch record - required information
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Other FDA inspections of Cosmax Bio, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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