Warning letter

CFH Laboratories LP: warning letter of Nov 13, 2001

FDA warning letter UCM178627 · New Jersey District Office

Key facts

Reference number UCM178627
Company CFH Laboratories LP
Subject Quality System Regulations for Medical Devices/Enzymatic Tablets
Issue date Nov 13, 2001
Posted date Nov 13, 2001
Issuing office New Jersey District Office
Product type Devices
CFR sections cited 820
Country 3
Inspection city Morris Plains
Inspection ZIP 07950-2443
Inspection start date Sep 4, 2001
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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