Novartis Pharmaceuticals Corporation
FDA inspection history across 2 sites, 2017 to 2024
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one Form 483; 2019: one Form 483; 2022: one Form 483; 2023: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Morris Plains, New Jersey.
- 2022–24Two Form 483s and one warning letter, at Morris Plains, New Jersey and New Jersey.
- 2022The longest 483 on file: 6 observations over 7 pages at Morris Plains, New Jersey.
Cited most
Across all Novartis Pharmaceuticals observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160(b)General requirements1
The complete Novartis Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Morris Plains, New Jersey
Four Form 483s · 2017 to 2024 · 16 observations
Latest: Form 483, Aug 8, 2024 →New Jersey
One warning letter · 2023
Latest: Warning letter, Aug 8, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-08 | 483 Form 483 | Morris Plains, New Jersey | 4 | $99 |
| 2023-08-08 | Warning letter Warning letter | New Jersey | — | $99 |
| 2022-12-09 | 483 Form 483 | Morris Plains, New Jersey | 6 | $99 |
| 2019-08-21 | 483 Form 483 | Morris Plains, New Jersey | 4 | $99 |
| 2017-04-07 | 483 Form 483 | Morris Plains, New Jersey | 2 | $99 |
Investigators on these documents
Ashley Burns (1)Denise Gavin (1)Jacqueline M. Diaz Albert (1)Joan Johnson (1)Kimberly L. Schultz (1)Laurel A. Beer (1)Randa Meihem (1)Susan M. Jackson (1)Thai D. Truong (1)Unnee Ranjan (1)Xinobin Lu (1)
FEI number 3010353512 · most recent document Aug 8, 2024
About Novartis Pharmaceuticals Corporation
How many FDA Form 483s has Novartis Pharmaceuticals Corporation received?
FDA Intel has 4 Form 483s on file for Novartis Pharmaceuticals Corporation; the most recent is dated Aug 8, 2024.
When was Novartis Pharmaceuticals Corporation last inspected by FDA?
The most recent FDA inspection document on file for Novartis Pharmaceuticals Corporation is a Form 483 dated Aug 8, 2024, for the site in Morris Plains, New Jersey.
What did FDA cite at Novartis Pharmaceuticals Corporation?
The regulations cited most in the observations on file for Novartis Pharmaceuticals Corporation are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times.
Has Novartis Pharmaceuticals Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Novartis Pharmaceuticals Corporation; the most recent is dated Aug 8, 2023.