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•United States

Ocenco, Incorporated, Pleasant Prairie, WI – FDA Inspections

Inspection records and compliance data for Ocenco, Incorporated in Pleasant Prairie, Wisconsin. 2 FDA inspections on record, last inspected April 20, 2012.

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Company Profile

This profile covers Ocenco, Incorporated based in Pleasant Prairie, Wisconsin, United States.

FDA Inspection History

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

First inspected March 11, 2010. Last inspected April 20, 2012.

Most cited issue areas

  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Documentation of disposition, justification, signature1 inspection
  • Procedure for analysis of data sources1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
April 20, 2012VAIMedical Devices & Rad Health · Compliance: Devices780454
March 11, 2010VAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance652468
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Company Information

Name

Ocenco, Incorporated

FEI Number

2127064

Address

10225 82nd Ave, Pleasant Prairie, Wisconsin 53158, United States

Country

United States

ID: 1dffc0e3-77c5-4e4a-bd55-a7cfa83415f1

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