FDA Inspection
The Fertility Center of OregonThe Fertility Center of Oregon – FDA Inspection, Jul 23, 2010
Record Details
This FDA Inspection record concerns The Fertility Center of Oregon, with an inspection on July 23, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 23, 2010
- Product Type
- Biologics
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ID · 326b2c1d-4e2e-461c-9ab8-488eb8dd7a31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 677923
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
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Other FDA inspections of The Fertility Center of Oregon
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2025 | Not classified | Seattle District Office | |
| April 13, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 27, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 20, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for The Fertility Center of Oregon
- FDA Inspection 1267800 - 2025-04-15
- FDA Inspection 1166992 - 2022-04-13
- FDA Inspection 1045971 - 2018-03-27
- FDA Inspection 963734 - 2016-02-10
- FDA Inspection 916538 - 2015-02-20
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