FDA Inspection
Westchester IVFWestchester IVF – FDA Inspection, Feb 19, 2015
Record Details
This FDA Inspection record concerns Westchester IVF, with an inspection on February 19, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Westchester IVF
- Inspection Date
- February 19, 2015
- Product Type
- Biologics
View Company Profile
ID · d130964d-c776-4dda-9dd0-c15b24af6114
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918290
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(c)Name and personal info on accompanying records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Westchester IVF
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 27, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 29, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 12, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 12, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Westchester IVF
- FDA Inspection 1310364 - 2026-03-09
- FDA Inspection 1183798 - 2022-10-27
- FDA Inspection 1085714 - 2019-03-29
- FDA Inspection 984424 - 2016-09-12
- FDA Inspection 838589 - 2013-06-12
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