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Prostalund AB, Lund, Sweden – FDA Inspections

Inspection records and compliance data for Prostalund AB in Lund. 2 FDA inspections on record, 1 Form 483, last inspected May 31, 2019.

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Company Profile

This profile covers Prostalund AB based in Lund, Sweden.

FDA Inspection History

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

First inspected April 17, 2009. Last inspected May 31, 2019.

Most cited issue areas

  • Design output - documentation1 inspection
  • Supplier oversight1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
May 31, 2019Not classifiedMedical Devices & Rad Health · Postmarket Assurance: Devices1092677
April 17, 2009NAIMedical Devices & Rad Health · Compliance: Devices580625
FDA documents

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

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Jan Bolinder, MD
Company Information

Name

Prostalund AB

FEI Number

3002591507

Address

Mobilvagen 10, Lund, Sweden

Country

Sweden

ID: 69b2cde7-4d18-4ea6-afde-3ddc627500af

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