Warning letter

Pfizer, Inc. [ARCHIVED]: warning letter of May 26, 2010

FDA warning letter 79704 · New York District Office

Key facts

Reference number 79704
Company Pfizer, Inc. [ARCHIVED]
Subject Postmarketing Adverse Drug Experience Reporting Requirements
Issue date May 26, 2010
Posted date May 26, 2010
Issuing office New York District Office
Product type Drugs
CFR sections cited 314.81, 203.31, 314.80, 203.37(a)(1), 203.37(a)(2), 203.31(d), 203.37(a)(3), 314.80(c)(1)(ii), 314.80(b), 314.80(c), 314.80(c)(1), 314.80(c)(2) and 1 more
Inspection city New York
Inspection ZIP 10017
Inspection start date Jun 29, 2009
Letter on fda.gov web.archive.org

At a glance

  • 10–99 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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