Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-17.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2023 – 17 Mar 2023 | Human Drugs | 483 | On file |
| 23 Mar 2021 – 25 Mar 2021 | Human Drugs | Clean | |
| 12 Nov 2018 – 16 Nov 2018 | Human Drugs | Clean | |
| 7 Jul 2014 – 11 Jul 2014 | Human Drugs | 483 | View 483 → |
| 20 Jun 2012 | Not recorded | 483 | On file |
| 9 Jan 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jul 2014
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Marvin D Jones, Patricia D Stahnke
11 Jul 2014
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Marvin D Jones, Patricia D Stahnke
11 Jul 2014
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Marvin D Jones, Patricia D Stahnke
11 Jul 2014
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Marvin D Jones, Patricia D Stahnke
11 Jul 2014
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Marvin D Jones, Patricia D Stahnke
Investigators
FDA investigators tied to this site in the record.
MRA DavisM2 insp.
Libia M Lugo1 insp.
Marvin D Jones1 insp.
Patricia D Stahnke1 insp.
Mary E Farbman1 insp.
Brenda W Uratani1 insp.
Anastasia G Lolas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind FUJIFILM Diosynth Biotechnologies UK Ltd's 4 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat