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•Singapore

OSTEOPORE INTERNATIONAL PTE LTD, Singapore, Singapore – FDA Inspections

Inspection records and compliance data for OSTEOPORE INTERNATIONAL PTE LTD in Singapore. 2 FDA inspections on record, 1 Form 483, last inspected September 26, 2024.

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Company Profile

This profile covers OSTEOPORE INTERNATIONAL PTE LTD based in Singapore, Singapore.

FDA Inspection History

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

First inspected February 21, 2019. Last inspected September 26, 2024.

Most cited issue areas

  • Design history file1 inspection
  • Nonconforming product control1 inspection
  • Report of Death or Serious Injury1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
September 26, 2024VAIMedical Devices & Rad Health · Compliance: Medical Devices1250099
February 21, 2019Not classifiedMedical Devices & Rad Health1083988
FDA documents

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

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Flextronics Manufacturing (Singapore) Pte. Ltd.
Leica Instruments (Singapore) Pte., Ltd.
Venture Corporation Limited
SP MANUFACTURING PTE LTD
Merit Medical Singapore Pte Ltd
Vela Operations Singapore Pte Ltd
Acme Monaco Asia Pte. Ltd.
Biomers Pte Ltd
Emerald Medical Services Pte. Ltd.
Resmed Singapore Pte Ltd
Company Information

Name

OSTEOPORE INTERNATIONAL PTE LTD

FEI Number

3007303685

Address

2 Tukang Innovation Grove, #09-06 Jtc Medtech Hub, Singapore, Singapore

Country

Singapore

ID: f35ccfae-048d-4235-a4c5-adda840f70d6

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