Company
United StatesCarolinas Fertility Institute, Winston Salem, NC – FDA Inspections
Inspection records and compliance data for Carolinas Fertility Institute in Winston Salem, North Carolina. 5 FDA inspections on record, last inspected May 02, 2025.
Company Profile
This profile covers Carolinas Fertility Institute based in Winston Salem, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 19, 2016. Last inspected May 2, 2025.
Most cited issue areas
- Determination based on screening and testing1 inspection
- Improper release prevention--storage, I.D.1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 2, 2025 | Not classified | Biologics | 1269744 |
| July 27, 2023 | NAI | Biologics · Blood and Blood Products | 1211469 |
| February 26, 2020 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1121329 |
| February 14, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1043604 |
| May 19, 2016 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 970575 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Carolinas Fertility Institute
FEI Number
3011497718
Address
3821 Forrestgate Dr, Winston Salem, North Carolina 27103, United States
Country
United States
ID: b22d3fc0-3144-4aa2-80d1-32320bb7162a