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FDA Inspection
•Extract Labs, Inc.•August 1, 2025

Extract Labs, Inc. – FDA Inspection, Aug 1, 2025

Record Details

This FDA Inspection record concerns Extract Labs, Inc., with an inspection on August 1, 2025, issued by the Denver District Office, covering foods & cosmetics.

Company
Extract Labs, Inc.
Inspection Date
August 1, 2025
Product Type
Foods & Cosmetics
Office
Denver District Office
Person
  • Nicholas S. Vasilakes (Investigator)
View Company Profile

ID · e7c995af-1219-4fcf-ad19-5cf57a6bb2ad

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1277235
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

9
  1. 21 CFR 111.123(b)(2)Quality control - batch, product specifications
  2. 21 CFR 111.205(a)Master manufacturing record - prepared
  3. 21 CFR 111.255(b)Batch record - complete
  4. 21 CFR 111.260Batch record - required information
  5. 21 CFR 111.27(d)(1)Equipment - taken apart
  6. 21 CFR 111.70(b)Specifications - components
  7. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  8. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  9. 21 CFR 111.83(a)Reserve sample - collect, hold

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