Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 Feb 2012
21 CFR 1271.47(a)
Design of procedures to ensure compliance
Cited by Alexander M Kay, Dianna D Wardlow-Dotter
15 Feb 2012
21 CFR 1271.60(b)
Identified as quarantined, distinguishable
Cited by Alexander M Kay, Dianna D Wardlow-Dotter
15 Feb 2012
21 CFR 1271.75(d)
Donors with risks not determined ineligible
Cited by Alexander M Kay, Dianna D Wardlow-Dotter
Inspected site
SSSeattle Sperm Bank LLCSeattle, 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 1271.60(b) | 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 |
Full 483 report
Get the verbatim text of all 4 observations
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