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Company
•Korea (the Republic of)

Nuga Medical Co., Ltd., Wonju, Korea (the Republic of) – FDA Inspections

Inspection records and compliance data for Nuga Medical Co., Ltd. in Wonju. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected December 08, 2022.

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Company Profile

This profile covers Nuga Medical Co., Ltd. based in Wonju, Korea (the Republic of).

FDA Inspection History

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

First inspected August 28, 2014. Last inspected December 8, 2022.

Most cited issue areas

  • DHR content1 inspection
  • Documentation1 inspection
  • Equipment control activity documentation1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
December 8, 2022VAIMedical Devices & Rad Health · Compliance: Devices1194084
July 27, 2018VAIMedical Devices & Rad Health · Compliance: Devices1060124
August 28, 2014OAIMedical Devices & Rad Health · Compliance: Devices898365
FDA documents

Warning Letters (1)

  • Warning Letters · August 28, 2014
People (1)
Steven D. Silverman
Person
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Medinol Ltd.
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Theo Manufacturing BV
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Interlab S.r.l.
Company Information

Name

Nuga Medical Co., Ltd.

FEI Number

3004006265

Address

185 Jiraeul-Lo, Jijeong-Myeon, Wonju, Korea (the Republic of)

Country

Korea (the Republic of)

ID: 0cf1dd61-d88d-4cfe-b1fb-447cd38d59bc

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