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FDA Inspection
•Empirical Labs, Incorporated•August 13, 2021

Empirical Labs, Incorporated – FDA Inspection, Aug 13, 2021

Record Details

This FDA Inspection record concerns Empirical Labs, Incorporated, with an inspection on August 13, 2021, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Empirical Labs, Incorporated
Inspection Date
August 13, 2021
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · dd47fb8a-3c3c-4938-98fb-91f06555501e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1149529
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

8
  1. 21 CFR 111.27(b)Instruments - calibration
  2. 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
  3. 21 CFR 111.75(h)Tests, examinations - scientifically valid
  4. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.353Manufacturing operations - written procedures
  7. 21 CFR 111.205(a)Master manufacturing record - unique formulation
  8. 21 CFR 111.255(b)Batch record - complete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Empirical Labs, Incorporated

3
DateClassificationOfficeProject area
September 19, 2018NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 21, 2015NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 2, 2011NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Empirical Labs, Incorporated
  • FDA Inspection 1069128 - 2018-09-19
  • FDA Inspection 946211 - 2015-08-21
  • FDA Inspection 736733 - 2011-08-02

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