Overview
- 25 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-24.
At a glance
Inspections
25
Form 483s
8
EIRs
17
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Oct 2025 – 24 Oct 2025 | Human Drugs | Clean | |
| 9 Dec 2024 – 13 Dec 2024 | Human Drugs | 483 | View 483 → |
| 26 Aug 2024 – 30 Aug 2024 | Human Drugs | Clean | |
| 15 Jul 2024 – 19 Jul 2024 | Biologics | Clean | |
| 11 Apr 2023 – 19 Apr 2023 | Human Drugs | Clean | |
| 12 Oct 2022 – 28 Oct 2022 | Human Drugs | Clean | |
| 16 Nov 2021 – 19 Nov 2021 | Human Drugs | Clean | |
| 24 May 2021 – 4 Jun 2021 | OTHER | Clean | |
| 29 Oct 2018 – 2 Nov 2018 | Human Drugs | Clean | |
| 2 Oct 2018 – 5 Oct 2018 | Human Drugs | Clean | |
| 9 Jul 2018 – 18 Jul 2018 | Human Drugs | 483 | View 483 → |
| 11 Jun 2018 – 21 Jun 2018 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Dec 2024
21 CFR 58.130(a)
Conduct: in accordance with protocol
Cited by Matthew C Watson, Erin M Mcdowell
13 Dec 2024
21 CFR 58.33(f)
Study director: transfer of data to archives
Cited by Matthew C Watson, Erin M Mcdowell
18 Jul 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Edmund F Mrak, Rapti D Madurawe, Chunsheng Cai, Hang N Guo
18 Jul 2018
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Edmund F Mrak, Rapti D Madurawe, Chunsheng Cai, Hang N Guo
18 Jul 2018
21 CFR 211.80(a)
Written Procedures Not Followed
Cited by Edmund F Mrak, Rapti D Madurawe, Chunsheng Cai, Hang N Guo
Investigators
FDA investigators tied to this site in the record.
Diane C Thibodeau4 insp.
Matthew C Watson3 insp.
M. P Murphy3 insp.
Darin S Wiegers2 insp.
Maya M Davis2 insp.
Meredith L Miller1 insp.
Erin M Mcdowell1 insp.
Hugh M Mcclure1 insp.
Asia D Clark1 insp.
Gabrielle J Swain1 insp.
Byungja E Marciante1 insp.
Jonah S Ufferfilge1 insp.
Stephanie C Mangigian1 insp.
Peter R Lenahan1 insp.
Nina Yang1 insp.
Edmund F Mrak1 insp.
Rapti D Madurawe1 insp.
Chunsheng Cai1 insp.
Hang N Guo1 insp.
Victoria M Daddeo1 insp.
Kent A Conforti1 insp.
Dien N Nguyen1 insp.
Nealie C Newberger1 insp.
Christopher Janik1 insp.
Michelle M Noe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | 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 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.55(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pfizer, Inc.'s 8 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