Novartis Manufacturing NV
Form 483 issued November 5, 2021 · Puurs-Sint-Amands, Belgium
- Inspection
- Oct 28 – Nov 5, 2021
- Investigator
- Wayne Seifert
- Observations
- 3
- Pages
- 2
- FEI number
- 3002037047
In short: On November 5, 2021, FDA issued a Form 483 with 3 observations to Novartis Manufacturing NV in Puurs-Sint-Amands, Belgium (FEI 3002037047) after an inspection that ran Oct 28 – Nov 5, 2021. The investigator was Wayne Seifert. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish production and process control and assessment to assure that the drug products you…
- 02
Revalidation of the for the…
- 03
Equipment used in manufacture of the drug product is not adequately maintained or of appropriate installation…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
The firmNovartis Manufacturing NV history
The site's inspection history, in date order.
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 Novartis Manufacturing NV?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Novartis Manufacturing NV?
Wayne Seifert is named on this Form 483, for the inspection of Oct 28 – Nov 5, 2021. Each investigator has a profile showing what they cite most.
When was Novartis Manufacturing NV inspected by FDA?
The inspection ran Oct 28 – Nov 5, 2021, and the Form 483 is dated November 5, 2021.
How do I get the full Form 483 for Novartis Manufacturing 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.