Juno Therapeutics, Inc.
FDA inspection history across 2 sites, 2020 to 2023
- 2
- Form 483s
- 1
- Response
- 1
- EIR
Every document, by year
- Form 483
- Response
- EIR
2020: one inspection report and one Form 483; 2021: one 483 response; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–23Two Form 483s, one inspection report and one 483 response, at Bothell, Washington and Washington.
- 2020The longest 483 on file: 6 observations over 8 pages at Bothell, Washington.
Cited most
Across all Juno Therapeutics observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Juno Therapeutics file.
All 4 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
Bothell, Washington
Two Form 483s and one inspection report · 2020 to 2023 · 9 observations
Latest: Form 483, Sep 20, 2023 →Washington
One 483 response · 2021
Latest: Response, Jan 5, 2021 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-20 | 483 Form 483 | Bothell, Washington | 3 | $99 |
| 2021-01-05 | Response 483 response | Washington | — | $199 |
| 2020-10-16 | EIR EIR | Bothell, Washington | — | $550 |
| 2020-10-16 | 483 Form 483 | Bothell, Washington | 6 | $99 |
Investigators on these documents
FEI number 3011834594 · most recent document Sep 20, 2023
About Juno Therapeutics, Inc.
How many FDA Form 483s has Juno Therapeutics, Inc. received?
FDA Intel has 2 Form 483s on file for Juno Therapeutics, Inc.; the most recent is dated Sep 20, 2023.
When was Juno Therapeutics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Juno Therapeutics, Inc. is a Form 483 dated Sep 20, 2023, for the site in Bothell, Washington.
What did FDA cite at Juno Therapeutics, Inc.?
The regulations cited most in the observations on file for Juno Therapeutics, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times.