Warning letter

Leisegang Feinmechanik-Optik GmbH: warning letter of Jul 11, 2012

FDA warning letter 305239 · Center for Devices and Radiological Health

Key facts

Reference number 305239
Company Leisegang Feinmechanik-Optik GmbH
Subject CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issue date Jul 11, 2012
Posted date Jul 11, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 803, 803.17, 820
Inspection city Berlin
Inspection start date Apr 16, 2012
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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