Overview
- 11 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-03.
At a glance
Inspections
11
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2026 – 3 Apr 2026 | Human Drugs | Clean | |
| 7 Aug 2023 – 14 Aug 2023 | Human Drugs | Clean | |
| 30 Sep 2019 – 4 Oct 2019 | Human Drugs | 483 | On file |
| 18 Jun 2018 – 22 Jun 2018 | Human Drugs | Clean | |
| 21 Aug 2017 – 1 Sep 2017 | Human Drugs | Clean | |
| 29 Jan 2014 – 12 Feb 2014 | Human Drugs | Clean | |
| 27 Feb 2012 | Not recorded | 483 | View 483 → |
| 23 Aug 2011 | Not recorded | Clean | |
| 20 Nov 2008 | Not recorded | 483 | On file |
| 18 Nov 2005 | Not recorded | Clean | |
| 17 Jan 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2012
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Lequita M Mayhew, Bradley J Maunder
27 Feb 2012
21 CFR 812.43(c)(4)(i)
No investigation agreement statement of commitment
Cited by Lequita M Mayhew, Bradley J Maunder
Investigators
FDA investigators tied to this site in the record.
Susan D Yuscius2 insp.
Colleen E Burke1 insp.
Yuanyuan Li1 insp.
Yiyue Zhang1 insp.
Debra L Boyd Seale1 insp.
Jeanne J Thai1 insp.
Debra I Love1 insp.
Lequita M Mayhew1 insp.
Bradley J Maunder1 insp.
Christina A Miller1 insp.
Bruce H Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.43(c)(4)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Astellas Pharma Global Development, Inc.'s 3 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