Overview
- 14 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-28.
At a glance
Inspections
14
Form 483s
5
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jun 2024 – 28 Jun 2024 | Biologics | Clean | |
| 13 May 2024 – 17 May 2024 | Human Drugs | 483 | On file |
| 5 Jun 2023 – 8 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 May 2023 – 16 May 2023 | Biologics | Clean | |
| 15 Jun 2022 – 22 Jun 2022 | Human Drugs | Clean | |
| 24 Jun 2021 – 2 Jul 2021 | Biologics | Clean | |
| 9 Nov 2017 – 16 Nov 2017 | Human Drugs | Clean | |
| 12 Jun 2017 – 21 Jun 2017 | Human Drugs | 483 | On file |
| 22 Jun 2015 – 30 Jun 2015 | Human Drugs | 483 | View 483 → |
| 10 Mar 2014 – 18 Mar 2014 | Human Drugs | Clean | |
| 23 Sep 2011 | Not recorded | 483 | On file |
| 13 Jul 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jun 2015
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Patricia D Stahnke
30 Jun 2015
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Patricia D Stahnke
Investigators
FDA investigators tied to this site in the record.
Susan M Jackson2 insp.
Wei Wang1 insp.
Kevin J Matthews1 insp.
Wayne E Seifert1 insp.
Catherine J Laufmann1 insp.
Lewis K Antwi1 insp.
MRA MunizN1 insp.
Zhongren Wu1 insp.
Laura Fontan1 insp.
Anissa M Cheung1 insp.
Satheesh Thomas1 insp.
Marion Michaelis1 insp.
Zhong Li1 insp.
Justin A Boyd1 insp.
Patricia D Stahnke1 insp.
James C Maclaughlin1 insp.
Megan A Haggerty1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pfizer Manufacturing Belgium NV'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