Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-23.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2020 – 23 Feb 2020 | Human Drugs | Clean | |
| 18 Sep 2017 – 22 Sep 2017 | Human Drugs | 483 | On file |
| 4 Apr 2017 – 13 Apr 2017 | Human Drugs | Clean | |
| 7 Apr 2014 – 11 Apr 2014 | Human Drugs | 483 | On file |
| 16 Mar 2012 | Not recorded | 483 | View 483 → |
| 14 Aug 2009 | Not recorded | 483 | View 483 → |
| 2 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Mar 2012
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Michael E Maselli, Charisse K Green
16 Mar 2012
21 CFR 211.192
Written record of investigation incomplete
Cited by Michael E Maselli, Charisse K Green
14 Aug 2009
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Debra I Love, Paul A Bonneau
14 Aug 2009
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Debra I Love, Paul A Bonneau
Investigators
FDA investigators tied to this site in the record.
MRA DavisM1 insp.
Doan T Nguyen1 insp.
Sangeeta M Khurana1 insp.
Jose R Lopez1 insp.
Marianela Aponte Cruz1 insp.
Michael E Maselli1 insp.
Charisse K Green1 insp.
Debra I Love1 insp.
Paul A Bonneau1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AstraZeneca 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