Warning letter

Stat Rx USA: warning letter of Oct 9, 2012

FDA warning letter 298059 · Atlanta District Office

Key facts

Reference number 298059
Company Stat Rx USA
Subject CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Issue date Oct 9, 2012
Posted date Oct 9, 2012
Issuing office Atlanta District Office
Product type Drugs
CFR sections cited 211.204, 211.166(a), 211.170(b)
Inspection city Gainesville
Inspection ZIP 30501
Inspection start date Feb 7, 2012
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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