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Company
•United States

Whitehall/Div of Acorn Engineering Co, City Of Industry, CA – FDA Inspections

Inspection records and compliance data for Whitehall/Div of Acorn Engineering Co in City Of Industry, California. 2 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected February 14, 2018.

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Company Profile

This profile covers Whitehall/Div of Acorn Engineering Co based in City Of Industry, California, United States.

FDA Inspection History

FDA inspections
2
OAI
1
VAI
0
NAI
0
Unclassified
1
Form 483s
2
Warning letters
1

First inspected March 23, 2017. Last inspected February 14, 2018.

Most cited issue areas

  • Design history file2 inspections
  • Individual Report of Malfunction2 inspections
  • Lack of or inadequate process validation2 inspections

FDA inspections (2)

DateResultFDA center(s)Insp. #
February 14, 2018Not classifiedMedical Devices & Rad Health · Compliance: Devices1041314
March 23, 2017OAIMedical Devices & Rad Health · Postmarket Assurance: Devices1006245
FDA documents

Warning Letters (1)

  • Warning Letters · March 23, 2017
People (1)
Shari J. Shambaugh
Person
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Company Information

Name

Whitehall/Div of Acorn Engineering Co

FEI Number

1000150265

Address

15125 Proctor Ave, City Of Industry, California 91746, United States

Country

United States

ID: 6fa35af0-15bf-4401-bb94-74f22bf4fe5c

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