Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2012-10-04.
At a glance
Inspections
1
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Oct 2012 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Oct 2012
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Melissa I Michurski
4 Oct 2012
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Melissa I Michurski
4 Oct 2012
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Melissa I Michurski
Investigators
FDA investigators tied to this site in the record.
Melissa I Michurski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Spes Medica srl's 1 Form 483
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