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FDA Inspection
•Guerlain•April 26, 2024

Guerlain – FDA Inspection, Apr 26, 2024

Record Details

This FDA Inspection record concerns Guerlain, with an inspection on April 26, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Guerlain
Inspection Date
April 26, 2024
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Jacob G. Lutz (FDA Associated Person)
View Company Profile

ID · 02c68a05-3673-404e-8646-005e23f80957

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1237962
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.194(a)(4)Data secured in course of each test
  3. 21 CFR 211.180(e)(1)Representative Number of Batches for Annual Review

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Guerlain

1
DateClassificationOfficeProject area
September 25, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Guerlain
  • FDA Inspection 948465 - 2015-09-25

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