Warning letter

Transox Inc: warning letter of Jun 8, 2015

FDA warning letter 448166 · Atlanta District Office

Key facts

Reference number 448166
Company Transox Inc
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Jun 8, 2015
Posted date Jun 23, 2015
Issuing office Atlanta District Office
Product type Drugs
CFR sections cited 211.165(a), 211.22(a)
Inspection city West Columbia
Inspection ZIP 29169
Inspection start date Nov 13, 2014
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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