Warning letter

Kentron Health Care, Inc.: warning letter of Mar 26, 2012

FDA warning letter 268177 · New Orleans District Office

Key facts

Reference number 268177
Company Kentron Health Care, Inc.
Subject Medical Device Reporting/Misbranded
Issue date Mar 26, 2012
Posted date Mar 26, 2012
Issuing office New Orleans District Office
Product type Devices
CFR sections cited 803, 803.3, 803.17(a), 803.20(c)(1), 820, 803.50(b), 803.50(b)(3)
Inspection city Springfield
Inspection ZIP 37172
Inspection start date Oct 5, 2011
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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