Warning letter

Ameriderm Laboratories, Ltd.: warning letter of Dec 2, 2013

FDA warning letter 406166 · New Jersey District Office

Key facts

Reference number 406166
Company Ameriderm Laboratories, Ltd.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Dec 2, 2013
Posted date Dec 2, 2013
Issuing office New Jersey District Office
Product type Drugs
CFR sections cited 211.22(b), 211.67(b), 211.84(d)(2), 211.100(a), 211.100(b), 211.160(b)
Inspection city Paterson
Inspection ZIP 07503
Inspection start date Feb 1, 2013
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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