Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-11.
At a glance
Inspections
6
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2022 – 11 Nov 2022 | Human Drugs | Clean | |
| 16 Sep 2019 – 17 Sep 2019 | Human Drugs | Clean | |
| 6 Nov 2017 – 10 Nov 2017 | Human Drugs | 483 | View 483 → |
| 6 Jul 2015 – 8 Jul 2015 | Human Drugs | 483 | View 483 → |
| 13 Jul 2013 – 18 Jul 2013 | Human Drugs | Clean | |
| 11 Nov 2011 | 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.
MRA McCulloughJ1 insp.
Michele L Obert1 insp.
Dien N Nguyen1 insp.
Torrance J Slayton1 insp.
Azza Talaat1 insp.
Edmund F Mrak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cosmo SpA's 2 Form 483s
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