Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-19.
At a glance
Inspections
8
Form 483s
4
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 19 Sep 2024 | Human Drugs | Clean | |
| 2 Apr 2019 – 5 Apr 2019 | Human Drugs | Clean | |
| 15 Oct 2018 – 22 Oct 2018 | Human Drugs | Clean | |
| 11 Jul 2016 – 15 Jul 2016 | Human Drugs | 483 | View 483 → |
| 24 Jul 2014 – 28 Jul 2014 | Human Drugs | Clean | |
| 2 Apr 2014 – 21 May 2014 | Human Drugs | 483 | On file |
| 30 Jan 2013 – 7 Feb 2013 | Human Drugs | 483 | View 483 → |
| 3 Aug 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2016
21 CFR 314.80(b)
Failure to develop written procedures
Cited by John P Mistler, Dien N Nguyen
15 Jul 2016
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by John P Mistler, Dien N Nguyen
15 Jul 2016
21 CFR 314.80(c)(1)(ii)
Failure to investigate serious, unexpected events
Cited by John P Mistler, Dien N Nguyen
7 Feb 2013
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Justine M Corson
3 Aug 2011
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Debra M Emerson, Stacey S Degarmo
Investigators
FDA investigators tied to this site in the record.
Asia D Clark1 insp.
Matthew C Watson1 insp.
Kent A Conforti1 insp.
John P Mistler1 insp.
Dien N Nguyen1 insp.
Darin S Wiegers1 insp.
Megan A Haggerty1 insp.
Ramon E Martinez1 insp.
Justine M Corson1 insp.
Debra M Emerson1 insp.
Stacey S Degarmo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Covis Pharma GmBH's 4 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