Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Mar 2011
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Lequita M Mayhew, Michael D Robinson, Sherea L Dillon, Debra Boyd Seale
1 Mar 2011
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Lequita M Mayhew, Michael D Robinson, Sherea L Dillon, Debra Boyd Seale
1 Mar 2011
21 CFR 1271.60(a)
Completion of eligibility determination
Cited by Lequita M Mayhew, Michael D Robinson, Sherea L Dillon, Debra Boyd Seale
1 Mar 2011
21 CFR 1271.75(d)
Donors with risks not determined ineligible
Cited by Lequita M Mayhew, Michael D Robinson, Sherea L Dillon, Debra Boyd Seale
1 Mar 2011
21 CFR 1271.75(e)
Abbreviated procedure
Cited by Lequita M Mayhew, Michael D Robinson, Sherea L Dillon, Debra Boyd Seale
Inspected site
MSMidwest Sperm Bank, LLCDowners Grove, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(a) | 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 1271.75(e) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere