Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Feb 2025
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Tyanna N Hadley, Mayar M Mussa
7 Feb 2025
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Tyanna N Hadley, Mayar M Mussa
7 Feb 2025
21 CFR 314.80(c)(1)(ii)
Failure to investigate serious, unexpected events
Cited by Tyanna N Hadley, Mayar M Mussa
7 Feb 2025
21 CFR 314.80(c)(2)(ii)(B)
Late submission of an ICSR
Cited by Tyanna N Hadley, Mayar M Mussa
Inspected site
NNNovo Nordisk Inc.Plainsboro, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 4 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere