Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-02.
At a glance
Inspections
8
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Nov 2022 – 2 Dec 2022 | Human Drugs | Clean | |
| 17 Oct 2019 – 25 Oct 2019 | Human Drugs | Clean | |
| 2 Jul 2018 – 10 Jul 2018 | Animal Drugs & Feeds | 483 | On file |
| 7 Jul 2016 – 15 Jul 2016 | Human Drugs | 483 | View 483 → |
| 10 Mar 2014 – 14 Mar 2014 | Human Drugs | 483 | On file |
| 28 Oct 2011 | Not recorded | 483 | View 483 → |
| 16 Jul 2009 | Not recorded | 483 | View 483 → |
| 12 Nov 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Linda F Murphy, Xiaoping Guan
15 Jul 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Linda F Murphy, Xiaoping Guan
15 Jul 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Linda F Murphy, Xiaoping Guan
15 Jul 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Linda F Murphy, Xiaoping Guan
15 Jul 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Linda F Murphy, Xiaoping Guan
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
Anastasia M Shields1 insp.
Christopher S Keating1 insp.
Vincent M Williams1 insp.
Linda F Murphy1 insp.
Xiaoping Guan1 insp.
Margaret M Annes1 insp.
Steven M Weinman1 insp.
Erika V Butler1 insp.
Simone E Pitts1 insp.
Susan M Jackson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CORDEN PHARMA SPA's 5 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