Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-29.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Feb 2024 – 29 Feb 2024 | Human Drugs | 483 | On file |
| 23 Mar 2022 – 31 Mar 2022 | Human Drugs | 483 | On file |
| 9 Nov 2021 – 12 Nov 2021 | Human Drugs | Clean | |
| 13 Sep 2018 – 21 Sep 2018 | Human Drugs | 483 | On file |
| 8 Dec 2016 – 16 Dec 2016 | Human Drugs | 483 | On file |
| 18 Jun 2015 – 26 Jun 2015 | Human Drugs | 483 | View 483 → |
| 5 Dec 2012 | Not recorded | 483 | On file |
| 12 Nov 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jun 2015
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Joey V Quitania, Rodney G Raiford
Investigators
FDA investigators tied to this site in the record.
Michael Shanks1 insp.
Yasamin Ameri1 insp.
Thuy T Nguyen1 insp.
Jeanne M Fringer1 insp.
MRA DavisM1 insp.
Jessica Hankins1 insp.
Reyes Candau-Chacon1 insp.
Ephrem T Hunde1 insp.
Francis A Guidry1 insp.
Xiaokuang Lai1 insp.
Joey V Quitania1 insp.
Rodney G Raiford1 insp.
Regina T Brown1 insp.
Parul M Patel1 insp.
Bruce H Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BSP Pharmaceuticals SpA's 6 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