Novo Nordisk Pharmaceutical Industries LP
Form 483 issued August 29, 2024 · Durham, North Carolina
- Inspection
- Aug 20 – Aug 29, 2024
- Investigator
- Sarah C. Zimmermann
- Observations
- 6
- Pages
- 7
- FEI number
- 3016799712
In short: On August 29, 2024, FDA issued a Form 483 with 6 observations to Novo Nordisk Pharmaceutical Industries LP in Durham, North Carolina (FEI 3016799712) after an inspection that ran Aug 20 – Aug 29, 2024. The investigator was Sarah C. Zimmermann. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment for adequate control over air pressure, humidity and temperature is not provided when appropriate for…
- 02
There is no written testing program designed to assess the stability…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Sarah C. Zimmermann
1 document · 2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in North Carolina.
The firmNovo Nordisk Pharmaceutical Industries LP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novo Nordisk Pharmaceutical Industries LP?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk Pharmaceutical Industries LP?
Sarah C. Zimmermann is named on this Form 483, for the inspection of Aug 20 – Aug 29, 2024. Each investigator has a profile showing what they cite most.
When was Novo Nordisk Pharmaceutical Industries LP inspected by FDA?
The inspection ran Aug 20 – Aug 29, 2024, and the Form 483 is dated August 29, 2024.
How do I get the full Form 483 for Novo Nordisk Pharmaceutical Industries LP?
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.