Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-07-01.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jun 2026 – 1 Jul 2026 | Human Drugs | Clean | |
| 3 Mar 2025 – 7 Mar 2025 | Human Drugs | 483 | View 483 → |
| 30 Oct 2024 – 7 Nov 2024 | Human Drugs | 483 | View 483 → |
| 31 Aug 2023 – 14 Sep 2023 | Human Drugs | Clean | |
| 21 Jun 2023 – 30 Jun 2023 | Human Drugs | Clean | |
| 16 Dec 2021 – 17 Dec 2021 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Mar 2025
FDCA 505-1(f)(4)
Failure to comply with REMS Implementation System
Cited by Meredith L Miller
Investigators
FDA investigators tied to this site in the record.
Jose A Torres2 insp.
Meredith L Miller1 insp.
Kent A Conforti1 insp.
Alanna L Mussawwir Bias1 insp.
Matthew C Watson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alexion Pharmaceuticals, Inc.'s 2 Form 483s
Source PDFs 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