Warning letter

Innolatex SDN. BHD. [ARCHIVED]: warning letter of May 18, 2011

FDA warning letter 179013 · Center for Devices and Radiological Health

Key facts

Reference number 179013
Company Innolatex SDN. BHD. [ARCHIVED]
Subject CGMP/QSR/Devices/Adulterated
Issue date May 18, 2011
Posted date May 18, 2011
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Port Klang
Inspection start date Jan 17, 2011
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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