Pfizer Manufacturing Belgium NV
FDA inspection history across 2 sites, 2021 to 2024
- 2
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2021: one inspection report; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–24Two Form 483s and one inspection report, at Puurs, Belgium and Puurs-Sint-Amands, Belgium.
- 2024The longest 483 on file: 3 observations over 2 pages at Puurs-Sint-Amands, Belgium.
Cited most
Across all Pfizer Manufacturing Belgium NV observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 820.100(b)Corrective and preventive action1
The complete Pfizer Manufacturing Belgium NV file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Puurs-Sint-Amands, Belgium
Two Form 483s · 2023 to 2024 · 4 observations
Latest: Form 483, May 17, 2024 →Puurs, Belgium
One inspection report · 2021
Latest: EIR, Jul 2, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-17 | 483 Form 483 | Puurs-Sint-Amands, Belgium | 3 | $99 |
| 2023-06-08 | 483 Form 483 | Puurs-Sint-Amands, Belgium | 1 | $99 |
| 2021-07-02 | EIR EIR | Puurs, Belgium | — | $550 |
Investigators on these documents
Anissa M. Cheung (1)Ayyappan Rathakrishnan (1)Catherine J. Laufmann (1)Laura Fontan (1)Susan M. Jackson (1)Wayne Seifert (1)Zhongren Wu (1)
FEI number 1000654629 · most recent document May 17, 2024
About Pfizer Manufacturing Belgium NV
How many FDA Form 483s has Pfizer Manufacturing Belgium NV received?
FDA Intel has 2 Form 483s on file for Pfizer Manufacturing Belgium NV; the most recent is dated May 17, 2024.
When was Pfizer Manufacturing Belgium NV last inspected by FDA?
The most recent FDA inspection document on file for Pfizer Manufacturing Belgium NV is a Form 483 dated May 17, 2024, for the site in Puurs-Sint-Amands, Belgium.
What did FDA cite at Pfizer Manufacturing Belgium NV?
The regulations cited most in the observations on file for Pfizer Manufacturing Belgium NV are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.