Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-21.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Nov 2024 – 21 Nov 2024 | Human Drugs | 483 | View 483 → |
| 13 Sep 2023 – 19 Sep 2023 | Human Drugs | Clean | |
| 9 Jul 2018 – 17 Jul 2018 | Human Drugs | 483 | View 483 → |
| 26 Jun 2017 – 4 Jul 2017 | Human Drugs | 483 | View 483 → |
| 23 Feb 2015 – 3 Mar 2015 | Human Drugs | 483 | View 483 → |
| 5 Oct 2012 | Not recorded | 483 | On file |
| 30 Oct 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jul 2018
21 CFR 211.25(b)
Supervisor Training/Education/Experience
Cited by Erik W Koester, Xiaoping Guan
17 Jul 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Erik W Koester, Xiaoping Guan
Investigators
FDA investigators tied to this site in the record.
Jeanne J Thai1 insp.
MRA B KambereM1 insp.
Erik W Koester1 insp.
Xiaoping Guan1 insp.
Darren S Brown1 insp.
Linda Thai1 insp.
Maya M Davis1 insp.
Stephen D Brown1 insp.
Michael E Maselli1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Istituto Biochimico Italiano Giovanni Lorenzini'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