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FDA Inspection
•Laboratoires Clarins•November 21, 2014

Laboratoires Clarins – FDA Inspection, Nov 21, 2014

Record Details

This FDA Inspection record concerns Laboratoires Clarins, with an inspection on November 21, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Laboratoires Clarins
Inspection Date
November 21, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 5fd8ac8c-a1c3-4464-b3f0-a4f7a538a68c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
907461
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

4
  1. 21 CFR 211.84(c)(4)Compositing of Sub Samples
  2. 21 CFR 211.22(c)Approve or reject procedures or specs
  3. 21 CFR 211.22(a)Lack of quality control unit
  4. 21 CFR 211.198(a)Reporting of adverse drug experience to FDA

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Laboratoires Clarins

2
DateClassificationOfficeProject area
October 14, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 21, 2018OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Laboratoires Clarins
  • FDA Inspection 1181478 - 2022-10-14
  • FDA Inspection 1066301 - 2018-09-21

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