Pfizer Manufacturing Belgium NV
Form 483 issued May 17, 2024 · Puurs-Sint-Amands, Belgium
- Inspection
- May 13 – May 17, 2024
- Investigators
- Ayyappan Rathakrishnan· Wayne Seifert
- Observations
- 3
- Pages
- 2
- FEI number
- 1000654629
In short: On May 17, 2024, FDA issued a Form 483 with 3 observations to Pfizer Manufacturing Belgium NV in Puurs-Sint-Amands, Belgium (FEI 1000654629) after an inspection that ran May 13 – May 17, 2024. The investigators were Ayyappan Rathakrishnan and Wayne Seifert. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures and process designed to prevent or detect microbiological contamination of drug products purporting to be…
- 02
A standard operating procedure in support of manufacture is not…
- 03
Utilities and an equipment system in support of manufacture…
This inspection in context
Ayyappan Rathakrishnan
2 documents · 2024–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Belgium.
The firmPfizer Manufacturing Belgium NV history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Manufacturing Belgium NV?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Pfizer Manufacturing Belgium NV?
Ayyappan Rathakrishnan and Wayne Seifert are named on this Form 483, for the inspection of May 13 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was Pfizer Manufacturing Belgium NV inspected by FDA?
The inspection ran May 13 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for Pfizer Manufacturing Belgium NV?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.