Warning letter

Laboratoires Clarins: warning letter of Apr 23, 2019

FDA warning letter 568157 · Center for Drug Evaluation and Research

Key facts

Reference number 568157
Company Laboratoires Clarins
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Apr 23, 2019
Posted date May 7, 2019
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 211.34, 211.192, 211.67(a), 211.100(a)
Inspection city Pontoise
Inspection start date Sep 17, 2018
Letter on fda.gov fda.gov

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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