Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-07-29.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Jul 2022 – 29 Jul 2022 | Human Drugs | Clean | |
| 25 Jan 2018 – 2 Feb 2018 | Human Drugs | 483 | View 483 → |
| 13 Jun 2016 – 21 Jun 2016 | Human Drugs | 483 | On file |
| 15 Sep 2014 – 22 Sep 2014 | Human Drugs | 483 | View 483 → |
| 22 Nov 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Sep 2014
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Carla A Norris, Karen E Dorazio
22 Sep 2014
21 CFR 211.111
Deviations of production time limits
Cited by Carla A Norris, Karen E Dorazio
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Angela E Glenn1 insp.
Dennis Cantellops Paite1 insp.
Katie L Penno1 insp.
Katie L Korchinski1 insp.
Carla A Norris1 insp.
Karen E Dorazio1 insp.
Janet L Bowen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.111 | 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 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Solupharm Pharmazeutische Erzeugnisse Gmbh's 3 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