Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-09.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2023 – 9 Feb 2023 | Medical Devices & Rad Health | Clean | |
| 10 Feb 2020 – 18 Feb 2020 | Animal Drugs & Feeds | 483 | View 483 → |
| 9 Sep 2019 – 17 Sep 2019 | Human Drugs | Clean | |
| 6 Feb 2017 – 14 Feb 2017 | Human Drugs | 483 | On file |
| 15 Oct 2015 – 22 Oct 2015 | Human Drugs | 483 | On file |
| 6 Feb 2014 – 14 Feb 2014 | Human Drugs | 483 | View 483 → |
| 10 Feb 2014 – 12 Feb 2014 | Human Drugs | 483 | On file |
| 17 Feb 2012 | Not recorded | Clean | |
| 9 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Feb 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Barbara J Breithaupt, Steven A Gonzales
14 Feb 2014
21 CFR 211.42(c)(2)
Rejected Material Area
Cited by Barbara J Breithaupt, Steven A Gonzales
Investigators
FDA investigators tied to this site in the record.
Barbara J Breithaupt2 insp.
Steven A Gonzales2 insp.
Tiki Dixon1 insp.
Mindy M Chou1 insp.
Nicholas L Paulin1 insp.
Yumi J Hiramine1 insp.
Ruo H Xu1 insp.
Michael R Goga1 insp.
Anita R Michael1 insp.
Susanna E Ford1 insp.
Carl A Huffman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Rommelag CDMO GmbH'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