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•Taiwan

Bora Pharmaceuticals Laboratories, Inc, Miaoli County, Taiwan – FDA Inspections

Inspection records and compliance data for Bora Pharmaceuticals Laboratories, Inc in Miaoli County. 7 FDA inspections on record, 1 Form 483, last inspected July 21, 2025.

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Company Profile

This profile covers Bora Pharmaceuticals Laboratories, Inc based in Miaoli County, Taiwan.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
3
NAI
3
Unclassified
1
Form 483s
1
Warning letters
0

First inspected June 18, 2009. Last inspected July 21, 2025.

Most cited issue areas

  • Control procedures to monitor and validate performance1 inspection
  • Written program not followed1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
July 21, 2025Not classifiedHuman Drugs1273032
May 24, 2019NAIHuman Drugs · Drug Quality Assurance1095577
February 17, 2017NAIHuman Drugs · Drug Quality Assurance1008321
April 15, 2016VAIHuman Drugs · Drug Quality Assurance971066
July 26, 2014VAIHuman Drugs · Drug Quality Assurance890281
July 26, 2012NAIHuman Drugs · Drug Quality Assurance797513
June 18, 2009VAIHuman Drugs · Drug Quality Assurance596124
FDA documents

Form 483s (1)

  • Form 483s · July 21, 2025
People (1)
Brandy N. Lepage
Person
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Company Information

Name

Bora Pharmaceuticals Laboratories, Inc

FEI Number

3007184570

Address

Hsinchu Science Park, No. 1 Kedong 3rd Rd.; Zhunan Township, Miaoli County, Taiwan

Country

Taiwan

ID: 9bb86ed9-7d7d-4886-a145-b9497462c295

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