Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-20.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Mar 2024 – 20 Mar 2024 | Biologics | 483 | View 483 → |
| 11 Feb 2019 – 15 Feb 2019 | Biologics | Clean | |
| 28 Jul 2016 – 4 Aug 2016 | Biologics | Clean | |
| 2 Oct 2014 – 30 Oct 2014 | Biologics | 483 | View 483 → |
| 10 Jul 2013 – 5 Aug 2013 | Biologics | 483 | View 483 → |
| 15 Sep 2011 | Not recorded | 483 | View 483 → |
| 1 Mar 2011 | Not recorded | 483 | View 483 → |
| 8 Jul 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Oct 2014
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Jennifer C Adams, Jennifer C Johnson
30 Oct 2014
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Jennifer C Adams, Jennifer C Johnson
30 Oct 2014
21 CFR 1271.55(a)(3)
Summary--records used to make determination
Cited by Jennifer C Adams, Jennifer C Johnson
Investigators
FDA investigators tied to this site in the record.
Adam J Taylor2 insp.
Erma Zaimova1 insp.
Brentley S Collins1 insp.
Jennifer C Adams1 insp.
Jennifer C Johnson1 insp.
Margaret Torres-Vazquez1 insp.
Lauren A Crivellone1 insp.
Laurie A Haxel1 insp.
Lequita M Mayhew1 insp.
Michael D Robinson1 insp.
Sherea L Dillon1 insp.
Debra Boyd Seale1 insp.
Jason F Chancey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.75(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Midwest Sperm Bank, LLC'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