Warning letter

AliMed Corporation: warning letter of Aug 19, 2008

FDA warning letter UCM1048172 · New England District Office

Key facts

Reference number UCM1048172
Company AliMed Corporation
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Aug 19, 2008
Posted date Aug 19, 2008
Issuing office New England District Office
Product type Devices
CFR sections cited 820, 806.20(b), 803, 803.17, 806, 806.10, 803.50(a)(1), 803.50(b)(1), 806.10(a)(1)
Country 3
Inspection city Dedham
Inspection ZIP 02026-2852
Inspection start date Jan 17, 2008
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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