Novo Nordisk US Bio Production Inc.
Form 483 issued July 25, 2023 · West Lebanon, New Hampshire
- Inspection
- Jul 12 – Jul 25, 2023
- Investigators
- Of His Yc Hy· Of Hs O. Ru
- Observations
- 3
- Pages
- 3
- FEI number
- 3012593913
In short: On July 25, 2023, FDA issued a Form 483 with 3 observations to Novo Nordisk US Bio Production Inc. in West Lebanon, New Hampshire (FEI 3012593913) after an inspection that ran Jul 12 – Jul 25, 2023. The investigators were Of His Yc Hy and Of Hs O. Ru. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.68 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
pane to clean, store, maintain and sanitize bulk drug substance manufacturing equipment and utensils to prevent…
- 02
Failure to exercise sufficient controls over computerized systems to…
- 03
Failure to ensure training is regularly conducted by qualified individuals and covers the particular operations…
This inspection in context
Of His Yc Hy
1 document · 2023
Cites 211.25 (personnel qualifications) more than any other section. Most of their documents are for sites in New Hampshire.
The firmNovo Nordisk US Bio Production Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novo Nordisk US Bio Production Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk US Bio Production Inc.?
Of His Yc Hy and Of Hs O. Ru are named on this Form 483, for the inspection of Jul 12 – Jul 25, 2023. Each investigator has a profile showing what they cite most.
When was Novo Nordisk US Bio Production Inc. inspected by FDA?
The inspection ran Jul 12 – Jul 25, 2023, and the Form 483 is dated July 25, 2023.
How do I get the full Form 483 for Novo Nordisk US Bio Production Inc.?
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.