Warning letter

Corepharma LLC [ARCHIVED]: warning letter of Jun 21, 2010

FDA warning letter 96446 · New Jersey District Office

Key facts

Reference number 96446
Company Corepharma LLC [ARCHIVED]
Subject Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals
Issue date Jun 21, 2010
Posted date Jun 21, 2010
Issuing office New Jersey District Office
Product type Drugs
CFR sections cited 211.165(f), 211.110(a), 211.110(c), 211.166(a), 211.192, 211.22(d), 211.46(c)
Inspection city Middlesex
Inspection ZIP 08846
Inspection start date Nov 24, 2009
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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