FDA Inspection
Valens Int. d.o.o.FDA Inspection 1274506 - Valens Int. d.o.o. - June 27, 2025
Record Details
This FDA Inspection record concerns Valens Int. d.o.o., with an inspection on June 27, 2025, issued by the Office of Inspections and Investigations, covering foods & cosmetics.
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ID · 82d4520b-d183-4df6-83e6-20336a2db2b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1274506
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
7- 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 111.503Written procedures - establish; returned dietary supplements
- 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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