Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-11-22.
At a glance
Inspections
7
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2019 – 22 Nov 2019 | Human Drugs | 483 | View 483 → |
| 5 Mar 2019 – 14 Mar 2019 | Human Drugs | 483 | On file |
| 26 Jun 2017 – 4 Jul 2017 | Human Drugs | Clean | |
| 7 Sep 2015 – 15 Sep 2015 | Human Drugs | Clean | |
| 16 Sep 2013 – 25 Sep 2013 | Human Drugs | Clean | |
| 28 Oct 2011 | Not recorded | Clean | |
| 13 Nov 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Nov 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Yumi J Hiramine, Susan T Hadman
22 Nov 2019
21 CFR 600.14(a)(1)
Who must report - manufacturer
Cited by Yumi J Hiramine, Susan T Hadman
Investigators
FDA investigators tied to this site in the record.
Bo Chi2 insp.
Yumi J Hiramine1 insp.
Susan T Hadman1 insp.
Wayne E Seifert1 insp.
Lynda L Perry1 insp.
Stephanie A Slater1 insp.
Vilmary Negron Rodriguez1 insp.
Sangeeta M Khurana1 insp.
Rebecca Rodriguez1 insp.
Tara L Breckenridge1 insp.
Mary E Farbman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | 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(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merz Pharma GmbH & Co KGaA's 3 Form 483s
Source PDFs 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