Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-03-04.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Feb 2022 – 4 Mar 2022 | Human Drugs | Clean | |
| 27 Jan 2020 – 12 Feb 2020 | Human Drugs | 483 | View 483 → |
| 9 Mar 2017 – 15 Mar 2017 | Human Drugs | Clean | |
| 11 May 2016 – 27 May 2016 | Human Drugs | 483 | View 483 → |
| 23 Mar 2015 – 31 Mar 2015 | Human Drugs | 483 | On file |
| 13 Mar 2014 – 18 Mar 2014 | Human Drugs | Clean | |
| 2 Feb 2012 | Not recorded | Clean | |
| 23 Feb 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Ruth A Williams1 insp.
Lavender M Huskey1 insp.
Angela Shepas1 insp.
Jacob W Reynolds1 insp.
Diane C Van Leeuwen1 insp.
Doan T Nguyen1 insp.
Arie Menachem1 insp.
Virgilio F Pacio1 insp.
Michael D Garcia1 insp.
Truong X Nguyen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.56(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Spectrum Pharmaceuticals, Inc.'s 3 Form 483s
Source PDFs, verbatim observations, 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