Novo Nordisk A/S
Form 483 issued May 4, 2023 · Kalundborg, Denmark
- Inspection
- Apr 27 – May 4, 2023
- Investigators
- Mikhail Ovanesov· Prabhu P. Raju· Sergey Akimov
- Observations
- 3
- Pages
- 7
- FEI number
- 3002807751
In short: On May 4, 2023, FDA issued a Form 483 with 3 observations to Novo Nordisk A/S in Kalundborg, Sjaelland (FEI 3002807751) after an inspection that ran Apr 27 – May 4, 2023. The investigators were Mikhail Ovanesov, Prabhu P. Raju, Sergey Akimov and Unnee Ranjan. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113 (2×)
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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Mikhail Ovanesov
4 documents · 2016–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Austria.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novo Nordisk A/S?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk A/S?
Mikhail Ovanesov, Prabhu P. Raju, Sergey Akimov and Unnee Ranjan are named on this Form 483, for the inspection of Apr 27 – May 4, 2023. Each investigator has a profile showing what they cite most.
When was Novo Nordisk A/S inspected by FDA?
The inspection ran Apr 27 – May 4, 2023, and the Form 483 is dated May 4, 2023.
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.