Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-02-21.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2019 – 21 Feb 2019 | Human Drugs | 483 | On file |
| 30 Jan 2017 – 3 Feb 2017 | Human Drugs | 483 | View 483 → |
| 12 Oct 2015 – 16 Oct 2015 | Human Drugs | 483 | On file |
| 10 Mar 2014 – 14 Mar 2014 | Human Drugs | Clean | |
| 30 Mar 2012 | Not recorded | 483 | On file |
| 11 Sep 2009 | Not recorded | 483 | On file |
| 6 Apr 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Alicia M Mozzachio2 insp.
Patric C Klotzbuecher1 insp.
Nadeem I Chaudhry1 insp.
James C Maclaughlin1 insp.
Marvin D Jones1 insp.
Sixto M Mercado Rios1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | 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 Rottendorf Pharma Gmbh's 5 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