Novo Nordisk A/S - 25a-B
FDA inspection history in Hilleroed, Denmark, 2020 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Hilleroed, Denmark.
- 2023One Form 483, at Hilleroed, Denmark.
- 2023The longest 483 on file: 2 observations over 2 pages at Hilleroed, Denmark.
Cited most
Across all Novo Nordisk A/S - 25a-B observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
The complete Novo Nordisk A/S - 25a-B 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
Hilleroed, Denmark
Two Form 483s · 2020 to 2023 · 3 observations
Latest: Form 483, Nov 7, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-07 | 483 Form 483 | Hilleroed, Denmark | 2 | $99 |
| 2020-01-17 | 483 Form 483 | Hilleroed, Denmark | 1 | $99 |
Investigators on these documents
Jin Cantellos (1)Laurimer Kuilan-Torres (1)Sangeeta M. Khurana (1)
FEI number 3003131673 · most recent document Nov 7, 2023
About Novo Nordisk A/S - 25a-B
How many FDA Form 483s has Novo Nordisk A/S - 25a-B received?
FDA Intel has 2 Form 483s on file for Novo Nordisk A/S - 25a-B; the most recent is dated Nov 7, 2023.
When was Novo Nordisk A/S - 25a-B last inspected by FDA?
The most recent FDA inspection document on file for Novo Nordisk A/S - 25a-B is a Form 483 dated Nov 7, 2023, for the site in Hilleroed, Denmark.
What did FDA cite at Novo Nordisk A/S - 25a-B?
The regulations cited most in the observations on file for Novo Nordisk A/S - 25a-B are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.192 (Production record review), 1 time.