Novartis Consumer Health
FDA inspection history in Lincoln, Nebraska, 2008 to 2021
- 4
- Form 483s
- 2
- EIRs
Every document, by year
- Form 483
- EIR
2008: one inspection report; 2011: one inspection report and one Form 483; 2012: one Form 483; 2013: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One inspection report, at Lincoln, Nebraska.
- 2011–13Three Form 483s and one inspection report, at Lincoln, Nebraska.
- 2011The longest 483 on file: 13 observations over 13 pages at Lincoln, Nebraska.
- 2021One Form 483, at Lincoln, Nebraska.
Cited most
Across all Novartis Consumer Health observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.198(a)Complaint files4
- 21 CFR 211.22(d)Responsibilities of quality control unit4
- 21 CFR 211.100(b)Written procedures; deviations2
- 21 CFR 211.166(a)Stability testing2
The complete Novartis Consumer Health file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Lincoln, Nebraska
Four Form 483s and two inspection reports · 2008 to 2021 · 30 observations
Latest: Form 483, Sep 30, 2021 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-09-30 | 483 Form 483 | Lincoln, Nebraska | 5 | $99 |
| 2013-02-14 | 483 Form 483 | Lincoln, Nebraska | 9 | $99 |
| 2012-01-20 | 483 Form 483 | Lincoln, Nebraska | 3 | $99 |
| 2011-07-08 | EIR EIR | Lincoln, Nebraska | — | $550 |
| 2011-07-08 | 483 Form 483 | Lincoln, Nebraska | 13 | $99 |
| 2008-09-11 | EIR EIR | Lincoln, Nebraska | — | $550 |
Investigators on these documents
Joseph R. Lambert (3)Eric M. Mueller (3)Jacob G. Lutz (1)Jessica E. H. Ensley (1)Lisa L. Flores (1)Sandra A. Boyd (1)Susanna E. Ford (1)Thuy T. Nguyen (1)Adree N. Anderson (1)Warren J. Lopicka (1)Eric M. Miller (1)
FEI number 1911445 · most recent document Sep 30, 2021
About Novartis Consumer Health
How many FDA Form 483s has Novartis Consumer Health received?
FDA Intel has 4 Form 483s on file for Novartis Consumer Health; the most recent is dated Sep 30, 2021.
When was Novartis Consumer Health last inspected by FDA?
The most recent FDA inspection document on file for Novartis Consumer Health is a Form 483 dated Sep 30, 2021, for the site in Lincoln, Nebraska.
What did FDA cite at Novartis Consumer Health?
The regulations cited most in the observations on file for Novartis Consumer Health are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.198(a) (Complaint files), 4 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 4 times.