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•Netherlands

Medisize bv, Hillegom, Netherlands – FDA Inspections

Inspection records and compliance data for Medisize bv in Hillegom. 3 FDA inspections on record, last inspected May 23, 2016.

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Company Profile

This profile covers Medisize bv based in Hillegom, Netherlands.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
3
NAI
0
Form 483s
0
Warning letters
0

First inspected November 4, 2010. Last inspected May 23, 2016.

Most cited issue areas

  • Equipment Installation, Placement, Specified Requirements1 inspection
  • Investigation of device failures1 inspection
  • Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
May 23, 2016VAIMedical Devices & Rad Health · Compliance: Devices982629
August 15, 2013VAIMedical Devices & Rad Health · Compliance: Devices844546
November 4, 2010VAIMedical Devices & Rad Health · Compliance: Devices700375
FDA documents

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

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FORTIMEDIX SURGICAL B.V.
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CAM Bioceramics B.V.
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NOBEL BIOCARE DISTRIBUTION CENTER BV
Company Information

Name

Medisize bv

FEI Number

3002598726

Address

Edisonstraat 1, Hillegom, Netherlands

Country

Netherlands

ID: c227cc8e-5d07-4ed8-a8dd-d4cbaab8d5eb

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