FDA Inspection
Bellingham IVF & Fertility CareBellingham IVF & Fertility Care – FDA Inspection, Sep 7, 2018
Record Details
This FDA Inspection record concerns Bellingham IVF & Fertility Care, with an inspection on September 7, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 73989e7b-b26c-4d59-8cd1-54b57461e6dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065093
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Bellingham IVF & Fertility Care
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2018 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 18, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 13, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 4, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Bellingham IVF & Fertility Care
- FDA Inspection 1039820 - 2018-01-31
- FDA Inspection 965390 - 2016-04-05
- FDA Inspection 883823 - 2014-06-18
- FDA Inspection 791271 - 2012-07-13
- FDA Inspection 591296 - 2009-06-04
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