Warning letter

PDS Manufacturing, Inc.: warning letter of Nov 24, 2008

FDA warning letter 41578 · Dallas District Office

Key facts

Reference number 41578
Company PDS Manufacturing, Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Nov 24, 2008
Posted date Nov 24, 2008
Issuing office Dallas District Office
Product type Devices
CFR sections cited 820
Inspection city Southlake
Inspection ZIP 76092-7534
Inspection start date Aug 25, 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:

Browse all FDA warning letters