Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-07.
At a glance
Inspections
11
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2023 – 7 Mar 2023 | Human Drugs | 483 | On file |
| 7 Feb 2022 – 15 Feb 2022 | Human Drugs | 483 | On file |
| 24 Feb 2021 – 26 Feb 2021 | Human Drugs | Clean | |
| 1 Aug 2019 – 9 Aug 2019 | Human Drugs | Clean | |
| 5 Mar 2018 – 8 Mar 2018 | Human Drugs | Clean | |
| 15 May 2017 – 23 May 2017 | Human Drugs | 483 | On file |
| 28 Nov 2016 – 6 Dec 2016 | Human Drugs | 483 | View 483 → |
| 8 Jun 2015 – 16 Jun 2015 | Human Drugs | 483 | On file |
| 12 Sep 2013 – 20 Sep 2013 | Human Drugs | 483 | On file |
| 19 Jul 2011 | Not recorded | 483 | On file |
| 4 Dec 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2016
21 CFR 211.63
Equipment Design, Size and Location
Cited by Truong X Nguyen, Djamila Harouaka
Investigators
FDA investigators tied to this site in the record.
Caryn M Mcnab2 insp.
Wendy G Tan1 insp.
Wayne E Seifert1 insp.
MRA DavisM1 insp.
Sangeeta M Khurana1 insp.
Susanna E Ford1 insp.
Steven Fong1 insp.
Diane L Raccasi1 insp.
Maxwell L Van Tassell1 insp.
Maria J Lopez- Barragan1 insp.
Ruth A Moore1 insp.
Truong X Nguyen1 insp.
Djamila Harouaka1 insp.
Helen B Ricalde1 insp.
Steven M Weinman1 insp.
Jennifer M Gogley1 insp.
Douglas A Campbell1 insp.
Maan S Abduldayem1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Rentschler Biopharma SE's 7 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