Novo Nordisk A/S
Form 483 issued March 25, 2024 · Kalundborg, Denmark
- Inspection
- Mar 15 – Mar 25, 2024
- Investigators
- Lindsey Brown· Maxwell Korang-Yeboah· Ralph M. Bernstein
- Observations
- 8
- Pages
- 2
- FEI number
- 3002807751
In short: On March 25, 2024, FDA issued a Form 483 with 8 observations to Novo Nordisk A/S in Kalundborg, Denmark (FEI 3002807751) after an inspection that ran Mar 15 – Mar 25, 2024. The investigators were Lindsey Brown, Maxwell Korang-Yeboah, Ralph M. Bernstein and Zachary Kraus. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 5 of 8 observations.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Substance manufacturing and processing unit operations that have been observed to be performed for (b)(4) DS…
- 04
Master production ~d control records lack complete…
This inspection in context
Lindsey Brown
4 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Belgium.
The firmNovo Nordisk A/S history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novo Nordisk A/S?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk A/S?
Lindsey Brown, Maxwell Korang-Yeboah, Ralph M. Bernstein and Zachary Kraus are named on this Form 483, for the inspection of Mar 15 – Mar 25, 2024. Each investigator has a profile showing what they cite most.
When was Novo Nordisk A/S inspected by FDA?
The inspection ran Mar 15 – Mar 25, 2024, and the Form 483 is dated March 25, 2024.
How do I get the full Form 483 for Novo Nordisk A/S?
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.