Company
United StatesTenderneeds Fertility LLC, Greenville, IN – FDA Inspections
Inspection records and compliance data for Tenderneeds Fertility LLC in Greenville, Indiana. 2 FDA inspections on record (2 OAI), 1 warning letter, last inspected September 29, 2021.
Company Profile
This profile covers Tenderneeds Fertility LLC based in Greenville, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 2
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected December 13, 2019. Last inspected September 29, 2021.
Most cited issue areas
- Design control - no procedures1 inspection
- Design history file1 inspection
- Determination based on screening and testing1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 29, 2021 | OAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 1153982 |
| December 13, 2019 | OAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 1112794 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Tenderneeds Fertility LLC
FEI Number
3012228225
Address
10162 Bradford Rd, Greenville, Indiana 47124, United States
Country
United States
ID: 90e98041-7744-45c1-9955-b97421665cc2