FDA Inspection
Seattle Sperm Bank LLCSeattle Sperm Bank LLC – FDA Inspection, May 24, 2011
Record Details
This FDA Inspection record concerns Seattle Sperm Bank LLC, with an inspection on May 24, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Seattle Sperm Bank LLC
- Inspection Date
- May 24, 2011
- Product Type
- Biologics
View Company Profile
ID · 3379b62b-b656-4fd9-83fb-ef2ca868dde4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 726921
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
- 21 CFR 1271.60(c)Shipped but not kept in quarantine
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Seattle Sperm Bank LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 27, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 28, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 27, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 14, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Seattle Sperm Bank LLC
- FDA Inspection 1259811 - 2025-01-29
- FDA Inspection 1095929 - 2019-06-27
- FDA Inspection 968183 - 2016-04-28
- FDA Inspection 893143 - 2014-08-27
- FDA Inspection 844687 - 2013-08-14
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