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FDA Inspection
•Optiwize Inc.•November 7, 2025

Optiwize Inc. – FDA Inspection, Nov 7, 2025

Record Details

This FDA Inspection record concerns Optiwize Inc., with an inspection on November 7, 2025, issued by the Dallas District Office, covering foods & cosmetics.

Company
Optiwize Inc.
Inspection Date
November 7, 2025
Product Type
Foods & Cosmetics
Office
Dallas District Office
Person
  • Khunnathee Stoner (Company Rep)
View Company Profile

ID · 82943b6c-35af-4bce-912c-5ad894cd4221

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1266396
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling, and Economics
Outcome
Form 483 issued

FDA Citations

9
  1. 21 CFR 111.120(b)Quality control operations - specifications; components, packaging, labels
  2. 21 CFR 111.130(b)Quality control operations -returned dietary supplement; salvage, redistribution
  3. 21 CFR 111.140(b)(2)Records - date and signature; review, approval, rejection
  4. 21 CFR 111.205(a)Master manufacturing record - prepared
  5. 21 CFR 111.255(b)Batch record - complete
  6. 21 CFR 111.365(i)Metal, foreign material
  7. 21 CFR 111.475(b)Records - written procedures holding and distribution; product distribution
  8. 21 CFR 111.70(e)Specifications - finished dietary supplement
  9. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient

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