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•Malaysia

MedDev Manufacturing Sdn Bhd, Klang, Malaysia – FDA Inspections

Inspection records and compliance data for MedDev Manufacturing Sdn Bhd in Klang. 2 FDA inspections on record, 2 Form 483s, last inspected May 04, 2023.

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Company Profile

This profile covers MedDev Manufacturing Sdn Bhd based in Klang, Malaysia.

FDA Inspection History

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

First inspected April 12, 2018. Last inspected May 4, 2023.

Most cited issue areas

  • Lack of or inadequate DHR procedures1 inspection
  • Procedures not adequately established or maintained1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
May 4, 2023NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1204932
April 12, 2018Not classifiedMedical Devices & Rad Health1050999
FDA documents

Form 483s (1)

  • Form 483s · May 4, 2023
People (1)
Dianiris C. Ayala
Person
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Company Information

Name

MedDev Manufacturing Sdn Bhd

FEI Number

3006307105

Address

115 Jalan Serunai 1, Klang, Malaysia

Country

Malaysia

ID: 47210d92-4674-475e-b165-87d96bd7bf93

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