Novartis Gene Therapies, Inc.
FDA inspection history across 4 sites, 2019 to 2024
- 3
- Form 483s
- 1
- Response
- 1
- EIR
Every document, by year
- Form 483
- Response
- EIR
2019: one 483 response, one Form 483 and one inspection report; 2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, one 483 response and one inspection report, at California; SAN DIEGO, California and San Diego, California.
- 2019The longest 483 on file: 5 observations over 5 pages at SAN DIEGO, California.
- 2024One Form 483, at Durham, North Carolina.
Cited most
Across all Novartis Gene Therapies observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.194(a)Laboratory records2
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 600.14(c)Reporting of biological product deviations by licensed manufacturers1
The complete Novartis Gene Therapies file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
SAN DIEGO, California
Two Form 483s · 2019 to 2021 · 6 observations
Latest: Form 483, Aug 27, 2021 →Durham, North Carolina
One Form 483 · 2024 · 2 observations
Latest: Form 483, Jan 26, 2024 →California
One 483 response · 2019
Latest: Response, Aug 23, 2019 →San Diego, California
One inspection report · 2019
Latest: EIR, Feb 15, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-26 | 483 Form 483 | Durham, North Carolina | 2 | $99 |
| 2021-08-27 | 483 Form 483 | SAN DIEGO, California | 1 | $99 |
| 2019-08-23 | Response 483 response | California | — | $199 |
| 2019-08-02 | 483 Form 483 | SAN DIEGO, California | 5 | $99 |
| 2019-02-15 | EIR EIR | San Diego, California | — | $550 |
Investigators on these documents
Andrew Byrnes (1)Burnell M. Henry (1)Eileen A. Liu (1)Linda Thai (1)Mihaly S. Ligmond (1)Scott Ballard (1)Thai D. Truong (1)Unnee Ranjan (1)
FEI number 3014617030 · most recent document Jan 26, 2024
About Novartis Gene Therapies, Inc.
How many FDA Form 483s has Novartis Gene Therapies, Inc. received?
FDA Intel has 3 Form 483s on file for Novartis Gene Therapies, Inc.; the most recent is dated Jan 26, 2024.
When was Novartis Gene Therapies, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Novartis Gene Therapies, Inc. is a Form 483 dated Jan 26, 2024, for the site in Durham, North Carolina.
What did FDA cite at Novartis Gene Therapies, Inc.?
The regulations cited most in the observations on file for Novartis Gene Therapies, Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.194(a) (Laboratory records), 2 times.