Warning letter

Phoenix Instruments, Inc.: warning letter of Nov 8, 2012

FDA warning letter 346158 · Chicago District Office

Key facts

Reference number 346158
Company Phoenix Instruments, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Nov 8, 2012
Posted date Nov 8, 2012
Issuing office Chicago District Office
Product type Devices
CFR sections cited 803, 803.50(a)(1), 820
Inspection city Lisle
Inspection ZIP 60532
Inspection start date Jul 10, 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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