Warning letter

A1 Engineering: warning letter of Nov 19, 2015

FDA warning letter 457666 · Los Angeles District Office

Key facts

Reference number 457666
Company A1 Engineering
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Nov 19, 2015
Posted date Nov 24, 2015
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 820, 807.81(b), 890.5660, 890.9(a)
Inspection city Irvine
Inspection ZIP 92618
Inspection start date Mar 2, 2015
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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