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FDA Inspection
•Eau Zone Huiles & Fragrances Lee•December 20, 2012

Eau Zone Huiles & Fragrances Lee – FDA Inspection, Dec 20, 2012

Record Details

This FDA Inspection record concerns Eau Zone Huiles & Fragrances Lee, with an inspection on December 20, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Eau Zone Huiles & Fragrances Lee
Inspection Date
December 20, 2012
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · e5f8867d-8458-4d3d-a2fc-f879eb7d885d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
825746
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

10
  1. 21 CFR 211.122(d)Label storage access limited to authorized personnel
  2. 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
  3. 21 CFR 211.188(b)(2)Identity of major equipment and lines used
  4. 21 CFR 211.188(b)(3)Identification of each component or in-process material
  5. 21 CFR 211.194(a)Complete test data included in records
  6. 21 CFR 211.125(a)Strict control not exercised over labeling issued
  7. 21 CFR 211.180(e)(2)Items to cover on annual reviews
  8. 21 CFR 211.67(b)Written procedures fail to include
  9. 21 CFR 211.192No written record of investigation
  10. 21 CFR 211.182Written records kept in individual logs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Eau Zone Huiles & Fragrances Lee

3
DateClassificationOfficeProject area
August 14, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 15, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 5, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Eau Zone Huiles & Fragrances Lee
  • FDA Inspection 1102752 - 2019-08-14
  • FDA Inspection 1035213 - 2017-12-15
  • FDA Inspection 959760 - 2016-02-05

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