Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-07-01.
At a glance
Inspections
4
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jun 2022 – 1 Jul 2022 | Human Drugs | 483 | View 483 → |
| 3 Mar 2022 – 11 Mar 2022 | Human Drugs | 483 | On file |
| 26 Apr 2021 – 4 May 2021 | Human Drugs | 483 | On file |
| 8 Nov 2018 – 16 Nov 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Jul 2022
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Lucila B Nwatu, Alan P Kurtzberg, Caryn M Mcnab
1 Jul 2022
21 CFR 211.192
Written record of investigation incomplete
Cited by Lucila B Nwatu, Alan P Kurtzberg, Caryn M Mcnab
16 Nov 2018
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Jeffrey P Raimondi, Linda F Murphy, Roger F Zabinski
16 Nov 2018
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Jeffrey P Raimondi, Linda F Murphy, Roger F Zabinski
16 Nov 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jeffrey P Raimondi, Linda F Murphy, Roger F Zabinski
Investigators
FDA investigators tied to this site in the record.
Lucila B Nwatu1 insp.
Alan P Kurtzberg1 insp.
Caryn M Mcnab1 insp.
Guerlain Ulysse1 insp.
Cynthia Jim1 insp.
Jeffrey P Raimondi1 insp.
Linda F Murphy1 insp.
Roger F Zabinski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | 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 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Industria Farmaceutica Galenica Senese Srl's 4 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