Warning letter

AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO.: warning letter of Jun 27, 2013

FDA warning letter 405746 · Center for Devices and Radiological Health

Key facts

Reference number 405746
Company AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO.
Subject Quality System Regulation for Medical Devices/Adulterated
Issue date Jun 27, 2013
Posted date Jun 27, 2013
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820, 820.40
Inspection city Kutlukent
Inspection start date Apr 15, 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:

Browse all FDA warning letters