Warning letter

Gibson Laboratories Inc [ARCHIVED]: warning letter of Nov 3, 2009

FDA warning letter 82745 · Cincinnati District Office

Key facts

Reference number 82745
Company Gibson Laboratories Inc [ARCHIVED]
Subject CGMP for Medical Devices/QS/Adulterated
Issue date Nov 3, 2009
Posted date Nov 3, 2009
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 820, 803.17
Inspection city Lexington
Inspection ZIP 40508
Inspection start date Aug 18, 2009
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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