Warning letter

Peace Medical Inc. [ARCHIVED]: warning letter of Jul 12, 2011

FDA warning letter 181412 · New Jersey District Office

Key facts

Reference number 181412
Company Peace Medical Inc. [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jul 12, 2011
Posted date Jul 12, 2011
Issuing office New Jersey District Office
Product type Devices
CFR sections cited 803, 803.11, 803.12(a), 820, 807.81(b)
Inspection city Wharton
Inspection ZIP 07885
Inspection start date Mar 29, 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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