Warning letter

Standard Textile Co Inc: warning letter of May 7, 2013

FDA warning letter 394883 · Cincinnati District Office

Key facts

Reference number 394883
Company Standard Textile Co Inc
Subject Premarket Approval/Misbranded/Adulterated
Issue date May 7, 2013
Posted date May 7, 2013
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 807.81(a)(3)(i), 807.81(b)
Inspection city Cincinnati
Inspection ZIP 45237
Inspection start date Feb 4, 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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