Novo Nordisk US Bio Production Inc.
FDA inspection history in West Lebanon, New Hampshire, 2020 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at West Lebanon, New Hampshire.
- 2020The longest 483 on file: 6 observations over 4 pages at West Lebanon, New Hampshire.
- 2023One Form 483, at West Lebanon, New Hampshire.
Cited most
Across all Novo Nordisk US Bio Production observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Novo Nordisk US Bio Production file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
West Lebanon, New Hampshire
Two Form 483s · 2020 to 2023 · 9 observations
Latest: Form 483, Jul 25, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-25 | 483 Form 483 | West Lebanon, New Hampshire | 3 | $99 |
| 2020-02-14 | 483 Form 483 | West Lebanon, New Hampshire | 6 | $99 |
Investigators on these documents
Arulvathani Arudchandran (1)Kathleen R. Jones (1)Of His Yc Hy (1)Of Hs O. Ru (1)
FEI number 3012593913 · most recent document Jul 25, 2023
About Novo Nordisk US Bio Production Inc.
How many FDA Form 483s has Novo Nordisk US Bio Production Inc. received?
FDA Intel has 2 Form 483s on file for Novo Nordisk US Bio Production Inc.; the most recent is dated Jul 25, 2023.
When was Novo Nordisk US Bio Production Inc. last inspected by FDA?
The most recent FDA inspection document on file for Novo Nordisk US Bio Production Inc. is a Form 483 dated Jul 25, 2023, for the site in West Lebanon, New Hampshire.
What did FDA cite at Novo Nordisk US Bio Production Inc.?
The regulations cited most in the observations on file for Novo Nordisk US Bio Production Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.25 (Personnel qualifications), 2 times.