Novo Nordisk A/S - 25a-B
Form 483 issued November 7, 2023 · Hilleroed, Denmark
- Inspection
- Oct 30 – Nov 7, 2023
- Investigator
- Laurimer Kuilan-Torres
- Observations
- 2
- Pages
- 2
- FEI number
- 3003131673
In short: On November 7, 2023, FDA issued a Form 483 with 2 observations to Novo Nordisk A/S - 25a-B in Hilleroed, Hovedstaden (FEI 3003131673) after an inspection that ran Oct 30 – Nov 7, 2023. The investigator was Laurimer Kuilan-Torres. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmNovo Nordisk A/S - 25a-B history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novo Nordisk A/S - 25a-B?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk A/S - 25a-B?
Laurimer Kuilan-Torres is named on this Form 483, for the inspection of Oct 30 – Nov 7, 2023. Each investigator has a profile showing what they cite most.
When was Novo Nordisk A/S - 25a-B inspected by FDA?
The inspection ran Oct 30 – Nov 7, 2023, and the Form 483 is dated November 7, 2023.
How do I get the full Form 483 for Novo Nordisk A/S - 25a-B?
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