Baxalta Belgium Manufacturing SA
Form 483 issued November 22, 2024 · Lessines, Belgium
- Inspection
- Nov 22, 2024
- Investigators
- Shafig Ahadi· Shafiq S. Ahadi
- Observations
- 1
- Pages
- 3
- FEI number
- 3002806503
In short: On November 22, 2024, FDA issued a Form 483 with 1 observation to Baxalta Belgium Manufacturing SA in Lessines, Belgium (FEI 3002806503) after an inspection that ran Nov 22, 2024. The investigators were Shafig Ahadi and Shafiq S. Ahadi. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188(b)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The batch production and control records are deficient in that they do not include the identity…
This inspection in context
Shafig Ahadi
6 documents · 2021–2025
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmBaxalta Belgium Manufacturing SA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxalta Belgium Manufacturing SA?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Baxalta Belgium Manufacturing SA?
Shafig Ahadi and Shafiq S. Ahadi are named on this Form 483, for the inspection of Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Baxalta Belgium Manufacturing SA inspected by FDA?
The inspection ran Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Baxalta Belgium Manufacturing SA?
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.