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Olympus Medical Products Czech, Prerov 4, Czech Republic – FDA Inspections

Inspection records and compliance data for Olympus Medical Products Czech in Prerov 4. 2 FDA inspections on record, 1 Form 483, last inspected April 12, 2017.

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Company Profile

This profile covers Olympus Medical Products Czech based in Prerov 4, Czech Republic.

FDA Inspection History

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

First inspected November 21, 2012. Last inspected April 12, 2017.

Most cited issue areas

  • Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
  • Lack of or inadequate procedures1 inspection
  • Production processes1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
April 12, 2017Not classifiedMedical Devices & Rad Health · Compliance: Devices1009642
November 21, 2012NAIMedical Devices & Rad Health · Postmarket Assurance: Devices809477
FDA documents

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

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Erika Matejkova, MD, MA
Medin A.S.
Ella CS, SRO
ICU Medical Czech Republic a. s.
Maxis A.S.
Hemcon Medical Technologies CZ sro
Company Information

Name

Olympus Medical Products Czech

FEI Number

3007960282

Address

Telickova 457/29, Prerov 4, Czech Republic

Country

Czech Republic

ID: 1c5bef11-4565-4a1b-ac9a-e9d3a43f38c5

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