Warning letter

Baxter Healthcare Corporation: warning letter of Mar 23, 2005

FDA warning letter UCM075334 · Florida District Office

Key facts

Reference number UCM075334
Company Baxter Healthcare Corporation
Subject Current Good Mfg Practice Regulation/Adulterated/Misbranded
Issue date Mar 23, 2005
Posted date Mar 23, 2005
Issuing office Florida District Office
Product type Devices
CFR sections cited 820, 803, 806, 806.10(a)(1)
Country 3
Inspection city Largo
Inspection ZIP 33773-5129
Inspection start date Oct 12, 2004
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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