Warning letter

The Standing Company: warning letter of May 7, 2013

FDA warning letter 396531 · Detroit District Office

Key facts

Reference number 396531
Company The Standing Company
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date May 7, 2013
Posted date May 7, 2013
Issuing office Detroit District Office
Product type Devices
CFR sections cited 806, 820.3(b), 820
Inspection city Saginaw
Inspection ZIP 48601
Inspection start date Mar 6, 2013
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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