Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-10.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2026 – 10 Apr 2026 | Human Drugs | 483 | On file |
| 10 Nov 2025 – 13 Nov 2025 | Medical Devices & Rad Health | Clean | |
| 30 Nov 2021 – 8 Dec 2021 | Human Drugs | 483 | On file |
| 8 Oct 2018 – 11 Oct 2018 | Human Drugs | 483 | View 483 → |
| 19 Jan 2017 – 27 Jan 2017 | Human Drugs | Clean | |
| 24 Mar 2014 – 28 Mar 2014 | Human Drugs | 483 | View 483 → |
| 29 May 2012 | Not recorded | Clean | |
| 25 Mar 2010 | Not recorded | Clean | |
| 18 Apr 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Oct 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by James A Lane, Truong X Nguyen, Yong Hu
Investigators
FDA investigators tied to this site in the record.
Jose A Cruz Gonzalez2 insp.
Allison A Aldridge1 insp.
Rowena S Nguyen1 insp.
Jeffrey J Thibodeau1 insp.
Thuy T Nguyen1 insp.
Wendy G Tan1 insp.
James A Lane1 insp.
Truong X Nguyen1 insp.
Yong Hu1 insp.
Saied A Asbagh1 insp.
Sneha S Patel1 insp.
Barbara J Breithaupt1 insp.
Barbara M Frazier1 insp.
Tiffani D Wilson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AstraZeneca AB's 5 Form 483s
Source PDFs, 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