Pfizer Manufacturing Belgium NV
Form 483 issued June 8, 2023 · Puurs-Sint-Amands, Belgium
- Inspection
- Jun 5 – Jun 8, 2023
- Investigator
- Catherine J. Laufmann
- Observations
- 1
- Pages
- 3
- FEI number
- 1000654629
In short: On June 8, 2023, FDA issued a Form 483 with 1 observation to Pfizer Manufacturing Belgium NV in Puurs-Sint-Amands, Antwerp (FEI 1000654629) after an inspection that ran Jun 5 – Jun 8, 2023. The investigator was Catherine J. Laufmann. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
This inspection in context
Catherine J. Laufmann
1 document · 2023
Cites 820.100(b) (corrective and preventive action) 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 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Manufacturing Belgium NV?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Pfizer Manufacturing Belgium NV?
Catherine J. Laufmann is named on this Form 483, for the inspection of Jun 5 – Jun 8, 2023. Each investigator has a profile showing what they cite most.
When was Pfizer Manufacturing Belgium NV inspected by FDA?
The inspection ran Jun 5 – Jun 8, 2023, and the Form 483 is dated June 8, 2023.
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.