Company
United StatesBoston IVF at The Women's Hospital, Newburgh, IN – FDA Inspections
Inspection records and compliance data for Boston IVF at The Women's Hospital in Newburgh, Indiana. 5 FDA inspections on record, 1 Form 483, last inspected September 09, 2025.
Company Profile
This profile covers Boston IVF at The Women's Hospital based in Newburgh, Indiana, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected May 6, 2013. Last inspected September 9, 2025.
Most cited issue areas
- Risk factors, clinical evidence1 inspection
- Testing, screening, donor eligibility procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 9, 2025 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1280953 |
| April 5, 2022 | NAI | Biologics · Vaccines and Allergenic Products | 1168585 |
| August 9, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1021251 |
| July 14, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 936272 |
| May 6, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 830516 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Boston IVF at The Women's Hospital
FEI Number
3010149285
Address
4199 Gateway Blvd Ste 2600, Newburgh, Indiana 47630, United States
Country
United States
ID: b233d5d2-5819-4a94-bf11-ef47dd9f4d81