Warning letter

American Quality Manufacturing, Inc. [ARCHIVED]: warning letter of Aug 9, 2011

FDA warning letter 184052 · Florida District Office

Key facts

Reference number 184052
Company American Quality Manufacturing, Inc. [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issue date Aug 9, 2011
Posted date Aug 9, 2011
Issuing office Florida District Office
Product type Devices
CFR sections cited 1040.20(e)(2)(iii), 820, 807.81(b), 1002, 1002.13, 1010, 1040.20, 1040.20(c)(2)(iii)
Inspection city Cocoa
Inspection ZIP 32922
Inspection start date Mar 28, 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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