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•United States

Peace Medical Inc., Wharton, NJ – FDA Inspections

Inspection records and compliance data for Peace Medical Inc. in Wharton, New Jersey. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected January 14, 2025.

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Company Profile

This profile covers Peace Medical Inc. based in Wharton, New Jersey, United States.

FDA Inspection History

FDA inspections
5
OAI
1
VAI
0
NAI
4
Form 483s
1
Warning letters
0

First inspected April 5, 2011. Last inspected January 14, 2025.

Most cited issue areas

  • Design control - no procedures1 inspection
  • Devices subject to device identification GUDID data submission requirements.1 inspection
  • DMR - not or inadequately maintained1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
January 14, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1258337
November 3, 2021NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1156667
February 8, 2018NAIMedical Devices & Rad Health · Compliance: Devices1044569
September 26, 2011NAIMedical Devices & Rad Health · Postmarket Assurance: Devices745805
April 5, 2011OAIMedical Devices & Rad Health · Postmarket Assurance: Devices718221
FDA documents

Form 483s (1)

  • Form 483s · January 14, 2025
People (2)
Jaro P. Perera
Person
Monica L. Gutierrez
Person
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Lone Star Medical Products, Inc.
Company Information

Name

Peace Medical Inc.

FEI Number

2243990

Address

105 W Dewey Ave Bldg C-12, Wharton, New Jersey 07885, United States

Country

United States

ID: 40e0485e-ad9c-4db8-9821-b62b69520a82

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