Warning letter

BTI Filtration: warning letter of Feb 27, 2007

FDA warning letter UCM076309 · Dallas District Office

Key facts

Reference number UCM076309
Company BTI Filtration
Subject QSR For Medical Device/Adulterated
Issue date Feb 27, 2007
Posted date Feb 27, 2007
Issuing office Dallas District Office
Product type Devices
CFR sections cited 807.81(b), 820, 803.17, 803, 82
Country 3
Inspection city Oklahoma City
Inspection ZIP 73105-3743
Inspection start date Aug 22, 2006
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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