Warning letter

Piezosurgery Inc. [ARCHIVED]: warning letter of Jun 8, 2010

FDA warning letter 113710 · Cincinnati District Office

Key facts

Reference number 113710
Company Piezosurgery Inc. [ARCHIVED]
Subject CGMP for Medical Devices/QS/Adulterated
Issue date Jun 8, 2010
Posted date Jun 8, 2010
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 820
Inspection city Hilliard
Inspection ZIP 43026
Inspection start date Mar 25, 2010
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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