Warning letter

BioDevelopment Associates, LLC: warning letter of Jul 2, 2004

FDA warning letter UCM146869 · Center for Devices and Radiological Health

Key facts

Reference number UCM146869
Company BioDevelopment Associates, LLC
Subject Good Laboratory Practices
Issue date Jul 2, 2004
Posted date Jul 2, 2004
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 58.185(a)(13), 58, 58.35, 58.185, 58.29(a), 58.35(a), 58.35(b)(1), 58.35(b)(5), 58.35(b)(6), 58.185(a)(5)
Country 3
Inspection city Mountlake Terrace
Inspection ZIP 98043-3137
Inspection start date Nov 10, 2003
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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