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•Taiwan

UBI Pharma, Inc., Hukou, Taiwan – FDA Inspections

Inspection records and compliance data for UBI Pharma, Inc. in Hukou. 7 FDA inspections on record, 5 Form 483s, last inspected October 14, 2025.

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Company Profile

This profile covers UBI Pharma, Inc. based in Hukou, Taiwan.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
4
NAI
0
Unclassified
3
Form 483s
5
Warning letters
0

First inspected August 6, 2012. Last inspected October 14, 2025.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Cleaning SOPs/instructions1 inspection
  • Laboratory Test Method Verification1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
October 14, 2025Not classifiedHuman Drugs1290852
June 6, 2023VAIHuman Drugs · Drug Quality Assurance1207579
June 20, 2019VAIHuman Drugs · Drug Quality Assurance1095285
December 21, 2018Not classifiedHuman Drugs1078315
May 4, 2018Not classifiedHuman Drugs1052235
July 18, 2014VAIHuman Drugs · Drug Quality Assurance890363
August 6, 2012VAIHuman Drugs · Drug Quality Assurance794206
FDA documents

Form 483s (3)

  • Form 483s · October 14, 2025
  • Form 483s · June 6, 2023
  • Form 483s
People (4)
David Gomes
Person
Kham Phommachanh
Person
Marcellinus D. Dordunoo
Person
Rajiv R. Srivastava
Person
Related Companies (10)

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

EUGIA Pharma Specialities Limited
Strides Pharma Science Limited
PharmaGend Global Medical Services Pte. Ltd.
Centaur Pharmaceuticals Private Ltd.
Strides Pharma, Inc.
Novel Laboratories, Inc. d.b.a Lupin Somerset
Otsuka Pharmaceutical Co., Ltd.
Caplin Steriles Limited
Torrent Pharmaceuticals Limited
Kelix bio (Malta) Ltd.
Company Information

Name

UBI Pharma, Inc.

FEI Number

3004713402

Address

45 Guangfu N. Road, Hukou, Taiwan

Country

Taiwan

ID: c7dfbd38-5fae-4a48-b959-a3abae44f320

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