Warning letter

National Biological Corp: warning letter of Jul 11, 2017

FDA warning letter 523732 · New England District Office

Key facts

Reference number 523732
Company National Biological Corp
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jul 11, 2017
Posted date Jul 18, 2017
Issuing office New England District Office
Product type Devices
CFR sections cited 806, 806.10, 806.2(k), 820
Inspection city Beachwood
Inspection ZIP 44122
Inspection start date Mar 6, 2017
Letter on fda.gov fda.gov

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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