Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-07-20.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jul 2022 – 20 Jul 2022 | Human Drugs | Clean | |
| 13 May 2019 – 24 May 2019 | Human Drugs | 483 | View 483 → |
| 15 Mar 2017 – 17 Mar 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 May 2019
21 CFR 312.50
General responsibilities of sponsors
Cited by Angela Shepas, Ni A Khin, Yangmin Ning
Investigators
FDA investigators tied to this site in the record.
Humberto Z Gomez1 insp.
Angela Shepas1 insp.
Ni A Khin1 insp.
Yangmin Ning1 insp.
Greg K Keshishyan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Puma Biotechnology, Inc.'s 1 Form 483
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