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  5. FUJIFILM Diosynth Biotechnologies UK Limited, Billingham, United Kingdom – FDA Inspections
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•United Kingdom

FUJIFILM Diosynth Biotechnologies UK Limited, Billingham, United Kingdom – FDA Inspections

Inspection records and compliance data for FUJIFILM Diosynth Biotechnologies UK Limited in Billingham. 7 FDA inspections on record, 2 Form 483s, last inspected September 01, 2026.

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Company Profile

This profile covers FUJIFILM Diosynth Biotechnologies UK Limited based in Billingham, United Kingdom.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
5
NAI
0
Unclassified
2
Form 483s
2
Warning letters
0

First inspected January 9, 2009. Last inspected September 1, 2026.

Most cited issue areas

  • Approve or reject procedures or specs1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Control procedures to monitor and validate performance1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
September 1, 2026Not classifiedHuman Drugs1339338
March 17, 2023VAIHuman Drugs · Drug Quality Assurance1200417
March 25, 2021VAIHuman Drugs · Drug Quality Assurance1155694
November 16, 2018Not classifiedHuman Drugs1097949
July 11, 2014VAIHuman Drugs · Drug Quality Assurance894612
June 20, 2012VAIHuman Drugs · Drug Quality Assurance790405
January 9, 2009VAIHuman Drugs · Drug Quality Assurance559762
FDA documents

Form 483s (2)

  • Form 483s · September 1, 2026
  • Form 483s · March 17, 2023
Other regulators (1)
  • UK MHRA · 4 inspections · last March 18, 2025
People (4)
Libia Lugo
Person
Libia M. Lugo
Person
Wayne E. Seifert
Person
Eileen A. Liu
Person
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Company Information

Name

FUJIFILM Diosynth Biotechnologies UK Limited

FEI Number

3007182567

Address

Belasis Avenue, Billingham, United Kingdom

Country

United Kingdom

ID: 1ab271fe-bbf2-4dec-a2b8-1ae59ca0f082

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