Warning letter

Cosmelab Co Ltd: warning letter of Jan 9, 2020

FDA warning letter 590480 · Center for Drug Evaluation and Research | CDER

Key facts

Reference number 590480
Company Cosmelab Co Ltd
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Jan 9, 2020
Posted date Jan 21, 2020
Issuing office Center for Drug Evaluation and Research | CDER
Product type Drugs
CFR sections cited 211.34, 211.22(a)
Inspection city Gangnam
Inspection start date Jul 15, 2019
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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