Warning letter

AstraZeneca AB: warning letter of Nov 9, 2001

FDA warning letter UCM178853 · Center for Devices and Radiological Health

Key facts

Reference number UCM178853
Company AstraZeneca AB
Subject Deviations from CGMP for Finished Pharmaceuticals
Issue date Nov 9, 2001
Posted date Nov 9, 2001
Issuing office Center for Devices and Radiological Health
Product type Drugs
Country 3
Inspection city Sodertalje
Inspection start date May 7, 2001
Letter on fda.gov web.archive.org

At a glance

  • 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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