Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-04.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2025 – 4 Nov 2025 | Biologics | Clean | |
| 16 Sep 2024 – 24 Sep 2024 | Biologics | Clean | |
| 11 Sep 2023 – 20 Sep 2023 | Human Drugs | 483 | View 483 → |
| 7 Oct 2020 – 16 Oct 2020 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Christopher R Czajka, Michael Araneta
20 Sep 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Christopher R Czajka, Michael Araneta
20 Sep 2023
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Christopher R Czajka, Michael Araneta
Investigators
FDA investigators tied to this site in the record.
Scott T Ballard1 insp.
Richard L Bartlett1 insp.
Priscilla M Pastrana1 insp.
Brentley S Pittman1 insp.
Christopher R Czajka1 insp.
Michael Araneta1 insp.
Eileen A Liu1 insp.
Prabhu P Raju1 insp.
Rabia Ballica1 insp.
Kimberly L Schultz1 insp.
David E Bailey1 insp.
Nirjal Bhattarai1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Juno Therapeutics, Inc.'s 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat