Warning letter

Advanced Sterilization Products [ARCHIVED]: warning letter of Mar 12, 2010

FDA warning letter 82084 · Los Angeles District Office

Key facts

Reference number 82084
Company Advanced Sterilization Products [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Mar 12, 2010
Posted date Mar 12, 2010
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 807.81(a)(3)(i), 820
Inspection city Irvine
Inspection ZIP 92618
Inspection start date Jun 1, 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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