Novo Nordisk US Bio Production Inc.
Form 483 issued February 14, 2020 · West Lebanon, New Hampshire
- Inspection
- Feb 6 – Feb 14, 2020
- Investigators
- Arulvathani Arudchandran· Kathleen R. Jones
- Observations
- 6
- Pages
- 4
- FEI number
- 3012593913
In short: On February 14, 2020, FDA issued a Form 483 with 6 observations to Novo Nordisk US Bio Production Inc. in West Lebanon, New Hampshire (FEI 3012593913) after an inspection that ran Feb 6 – Feb 14, 2020. The investigators were Arulvathani Arudchandran and Kathleen R. Jones. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls are…
- 02
In-process hold times are…
- 03
Corrective actions are not…
- 04
Sampling is inadequate to demonstrate cleaning effectiveness throughout the…
This inspection in context
Arulvathani Arudchandran
1 document · 2020
Cites 211.160 (general requirements) 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 211.160
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 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Novo Nordisk US Bio Production Inc.?
Arulvathani Arudchandran and Kathleen R. Jones are named on this Form 483, for the inspection of Feb 6 – Feb 14, 2020. Each investigator has a profile showing what they cite most.
When was Novo Nordisk US Bio Production Inc. inspected by FDA?
The inspection ran Feb 6 – Feb 14, 2020, and the Form 483 is dated February 14, 2020.
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.