Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-11-11.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2022 – 11 Nov 2022 | Human Drugs | 483 | View 483 → |
| 13 Sep 2022 – 14 Sep 2022 | Human Drugs | Clean | |
| 2 Jul 2018 – 6 Jul 2018 | Human Drugs | Clean | |
| 20 Oct 2014 – 24 Oct 2014 | Human Drugs | Clean | |
| 17 Nov 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Nov 2022
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Ileana Barreto-Pettit
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit1 insp.
MRA M BarbosaR1 insp.
Felix Maldonado1 insp.
Kham Phommachanh1 insp.
Karen C Daugherty1 insp.
Randy L Self1 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 | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Corden Pharma GmbH's 1 Form 483
Source PDFs 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