Novo Nordisk A/S
FDA inspection history in Kalundborg, Denmark, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24Two Form 483s, at Kalundborg, Denmark.
- 2024The longest 483 on file: 8 observations over 2 pages at Kalundborg, Denmark.
Cited most
Across all Novo Nordisk A/S observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.192Production record review1
The complete Novo Nordisk A/S file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Kalundborg, Denmark
Two Form 483s · 2023 to 2024 · 11 observations
Latest: Form 483, Mar 25, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-25 | 483 Form 483 | Kalundborg, Denmark | 8 | $99 |
| 2023-05-04 | 483 Form 483 | Kalundborg, Denmark | 3 | $99 |
Investigators on these documents
Lindsey Brown (1)Maxwell Korang-Yeboah (1)Mikhail Ovanesov (1)Prabhu P. Raju (1)Ralph M. Bernstein (1)Sergey Akimov (1)Unnee Ranjan (1)Zachary Kraus (1)
FEI number 3002807751 · most recent document Mar 25, 2024
About Novo Nordisk A/S
How many FDA Form 483s has Novo Nordisk A/S received?
FDA Intel has 2 Form 483s on file for Novo Nordisk A/S; the most recent is dated Mar 25, 2024.
When was Novo Nordisk A/S last inspected by FDA?
The most recent FDA inspection document on file for Novo Nordisk A/S is a Form 483 dated Mar 25, 2024, for the site in Kalundborg, Denmark.
What did FDA cite at Novo Nordisk A/S?
The regulations cited most in the observations on file for Novo Nordisk A/S are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.