Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-13.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2025 – 13 Feb 2025 | Human Drugs | 483 | On file |
| 29 Aug 2023 – 31 Aug 2023 | Human Drugs | Clean | |
| 12 Aug 2019 – 16 Aug 2019 | Human Drugs | 483 | On file |
| 13 Feb 2017 – 17 Feb 2017 | Human Drugs | 483 | On file |
| 17 Nov 2014 – 20 Nov 2014 | Human Drugs | 483 | On file |
| 29 Nov 2012 | Not recorded | 483 | On file |
| 26 Feb 2010 | Not recorded | Clean | |
| 9 Apr 2009 | Not recorded | 483 | On file |
| 19 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2014
21 CFR 211.194(b)
Test method modification records not maintained
Cited by Timothy T Kapsala
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez1 insp.
Michael T Cyrus1 insp.
MRA MunizN1 insp.
Charles L Zhou1 insp.
Lucila B Nwatu1 insp.
Timothy T Kapsala1 insp.
Michele L Obert1 insp.
Yumi J Hiramine1 insp.
Gwyn G Dickinson1 insp.
Felix Maldonado1 insp.
Paraluman S Leonin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nordmark Pharma GmbH'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