FDA Inspection
New England Fertility InstituteNew England Fertility Institute – FDA Inspection, Jan 16, 2014
Record Details
This FDA Inspection record concerns New England Fertility Institute, with an inspection on January 16, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 16, 2014
- Product Type
- Biologics
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ID · cf1ba243-64e1-449d-99c6-c0b9c82a4b85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862475
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New England Fertility Institute
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 9, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 25, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 6, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 23, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for New England Fertility Institute
- FDA Inspection 1222664 - 2023-11-07
- FDA Inspection 1156769 - 2021-11-09
- FDA Inspection 1060495 - 2018-07-25
- FDA Inspection 968604 - 2016-05-06
- FDA Inspection 768775 - 2012-02-23
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