Warning letter

Medisca Inc: warning letter of Nov 25, 2015

FDA warning letter 428290 · New York District Office

Key facts

Reference number 428290
Company Medisca Inc
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date Nov 25, 2015
Posted date Dec 8, 2015
Issuing office New York District Office
Product type Drugs
CFR sections cited 201.120(b), 201.128
Inspection city Plattsburgh
Inspection ZIP 12901
Inspection start date Feb 17, 2014
Letter on fda.gov web.archive.org

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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