Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-08.
At a glance
Inspections
9
Form 483s
6
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Aug 2023 – 8 Sep 2023 | Biologics | 483 | View 483 → |
| 8 Sep 2020 – 10 Sep 2020 | Human Drugs | Clean | |
| 4 Mar 2019 – 8 Mar 2019 | Biologics | 483 | On file |
| 14 Nov 2016 – 22 Nov 2016 | Human Drugs | 483 | View 483 → |
| 1 Dec 2014 – 9 Dec 2014 | Human Drugs | 483 | View 483 → |
| 18 Oct 2012 | Not recorded | Clean | |
| 14 Sep 2010 | Not recorded | 483 | On file |
| 13 Nov 2009 | Not recorded | 483 | On file |
| 20 Sep 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Sep 2023
21 CFR 211.194(a)(2)
Suitability of testing methods verified
Cited by Roger F Zabinski, Laurel A Beer
8 Sep 2023
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Roger F Zabinski, Laurel A Beer
8 Sep 2023
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Roger F Zabinski, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Roger F Zabinski1 insp.
Laurel A Beer1 insp.
MRA DavisM1 insp.
Pankaj H Amin1 insp.
Hector A Carrero1 insp.
Toyin B Oladimeji1 insp.
Nutan Mytle1 insp.
Victoria A Wagoner1 insp.
Kim L Thomas Cruse1 insp.
Bonita S Chester1 insp.
Paul A Bonneau1 insp.
Karen E Dorazio1 insp.
Bo Chi1 insp.
Mary E Farbman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | 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 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind IDT Biologika GmbH's 6 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