Warning letter

MTI Precision Products LLC.: warning letter of Jun 6, 2014

FDA warning letter 431350 · New Jersey District Office

Key facts

Reference number 431350
Company MTI Precision Products LLC.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jun 6, 2014
Posted date Jun 24, 2014
Issuing office New Jersey District Office
Product type Devices
CFR sections cited 806, 820, 806.10(a)
Inspection city Coatesville
Inspection ZIP 19320
Inspection start date Apr 17, 2014
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