Warning letter

Tango3 LLC: warning letter of May 23, 2012

FDA warning letter 287257 · Cincinnati District Office

Key facts

Reference number 287257
Company Tango3 LLC
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date May 23, 2012
Posted date May 23, 2012
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 807.81(a)(3)(i), 820, 820.3(b), 807.81(b)
Inspection city Louisville
Inspection ZIP 40299
Inspection start date Jan 11, 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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