Novartis Manufacturing NV
FDA inspection history in Puurs-Sint-Amands, Belgium, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Puurs-Sint-Amands, Belgium.
Cited most
Across all Novartis Manufacturing NV observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.63Equipment design, size, and location1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Novartis Manufacturing NV file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Puurs-Sint-Amands, Belgium
One Form 483 · 2021 · 3 observations
Latest: Form 483, Nov 5, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-05 | 483 Form 483 | Puurs-Sint-Amands, Belgium | 3 | $99 |
Investigators on these documents
FEI number 3002037047 · most recent document Nov 5, 2021
About Novartis Manufacturing NV
How many FDA Form 483s has Novartis Manufacturing NV received?
FDA Intel has 1 Form 483 on file for Novartis Manufacturing NV; the most recent is dated Nov 5, 2021.
When was Novartis Manufacturing NV last inspected by FDA?
The most recent FDA inspection document on file for Novartis Manufacturing NV is a Form 483 dated Nov 5, 2021, for the site in Puurs-Sint-Amands, Belgium.
What did FDA cite at Novartis Manufacturing NV?
The regulations cited most in the observations on file for Novartis Manufacturing NV are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.63 (Equipment design, size, and location), 1 time.