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ELOS MEDTECH PINOL A/S, Gorlose, Denmark – FDA Inspections

Inspection records and compliance data for ELOS MEDTECH PINOL A/S in Gorlose. 3 FDA inspections on record, 1 Form 483, last inspected February 07, 2019.

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Company Profile

This profile covers ELOS MEDTECH PINOL A/S based in Gorlose, Denmark.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
1
Form 483s
1
Warning letters
0

First inspected September 24, 2010. Last inspected February 7, 2019.

Most cited issue areas

  • Lack of or inadequate procedures2 inspections
  • Acceptable supplier records, inadequate records1 inspection
  • Contamination control, Lack of or inadequate procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
February 7, 2019VAIMedical Devices & Rad Health · Compliance: Devices1078835
November 21, 2013NAIMedical Devices & Rad Health · Compliance: Devices864555
September 24, 2010VAIMedical Devices & Rad Health · Compliance: Devices685840
FDA documents

Form 483s (1)

  • Form 483s · February 7, 2019
People (1)
John A. Sciacchitano
Person
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Company Information

Name

ELOS MEDTECH PINOL A/S

FEI Number

3007689689

Address

Engvej 33, Gorlose, Denmark

Country

Denmark

ID: 78979286-b8b4-47cc-80d1-7ff458c794b3

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