Novo Nordisk A/S - 25a-B
Form 483 issued January 17, 2020 · Hilleroed, Denmark
- Inspection
- Jan 15 – Jan 17, 2020
- Investigators
- Jin Cantellos· Sangeeta M. Khurana
- Observations
- 1
- Pages
- 3
- FEI number
- 3003131673
In short: On January 17, 2020, FDA issued a Form 483 with 1 observation to Novo Nordisk A/S - 25a-B in Hilleroed, Hovedstaden (FEI 3003131673) after an inspection that ran Jan 15 – Jan 17, 2020. The investigators were Jin Cantellos and Sangeeta M. Khurana. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Jin Cantellos
1 document · 2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Denmark.
The firmNovo Nordisk A/S - 25a-B history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novo Nordisk A/S - 25a-B?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk A/S - 25a-B?
Jin Cantellos and Sangeeta M. Khurana are named on this Form 483, for the inspection of Jan 15 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was Novo Nordisk A/S - 25a-B inspected by FDA?
The inspection ran Jan 15 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 483 for Novo Nordisk A/S - 25a-B?
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