Warning letter

Pointcare Technologies, Inc [ARCHIVED]: warning letter of Jun 14, 2011

FDA warning letter 191652 · New England District Office

Key facts

Reference number 191652
Company Pointcare Technologies, Inc [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jun 14, 2011
Posted date Jun 14, 2011
Issuing office New England District Office
Product type Devices
CFR sections cited 820
Inspection city Marlborough
Inspection ZIP 01752
Inspection start date Mar 25, 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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