FDA Inspection
Boston IVF at The Women's HospitalBoston IVF at The Women's Hospital – FDA Inspection, Sep 9, 2025
Record Details
This FDA Inspection record concerns Boston IVF at The Women's Hospital, with an inspection on September 9, 2025, issued by the Detroit District Office, covering biologics.
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ID · 89a3e5aa-6d1c-423b-9c1e-fa80eb57dae9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280953
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston IVF at The Women's Hospital
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 9, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 14, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 6, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Boston IVF at The Women's Hospital
- FDA Inspection 1168585 - 2022-04-05
- FDA Inspection 1021251 - 2017-08-09
- FDA Inspection 936272 - 2015-07-14
- FDA Inspection 830516 - 2013-05-06
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