FDA Inspection
FUJIFILM Diosynth Biotechnologies UK LimitedFUJIFILM Diosynth Biotechnologies UK Limited – FDA Inspection, Jul 11, 2014
Record Details
This FDA Inspection record concerns FUJIFILM Diosynth Biotechnologies UK Limited, with an inspection on July 11, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 11, 2014
- Product Type
- Drugs
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ID · ac5f17ff-d054-4ba5-9a1a-a21b8ebc2b8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894612
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(c)Approve or reject procedures or specs
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Other FDA inspections of FUJIFILM Diosynth Biotechnologies UK Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2026 | Not classified | Office of Inspections and Investigations | |
| March 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 25, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2018 | Not classified | Office of Inspections and Investigations | |
| June 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for FUJIFILM Diosynth Biotechnologies UK Limited
- FDA Inspection 1339338 - 2026-09-01
- FDA Inspection 1200417 - 2023-03-17
- FDA Inspection 1155694 - 2021-03-25
- FDA Inspection 1097949 - 2018-11-16
- FDA Inspection 790405 - 2012-06-20
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