Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-14.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Mar 2023 – 14 Mar 2023 | Human Drugs | 483 | View 483 → |
| 4 Jun 2018 – 8 Jun 2018 | Human Drugs | 483 | View 483 → |
| 1 Sep 2016 – 7 Sep 2016 | Human Drugs | Clean | |
| 10 Mar 2014 – 18 Mar 2014 | Human Drugs | 483 | On file |
| 7 May 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jun 2018
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Jogy George, Rodney G Raiford
Investigators
FDA investigators tied to this site in the record.
Michael A Charles1 insp.
Jogy George1 insp.
Rodney G Raiford1 insp.
Tajah L Blackburn1 insp.
Daniel J Roberts1 insp.
Steven C Madzo1 insp.
Douglas A Campbell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 Debiopharm Research & Manufacturing SA's 4 Form 483s
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