Company
United StatesWestlake IVF, LLC, Austin, TX – FDA Inspections
Inspection records and compliance data for Westlake IVF, LLC in Austin, Texas. 5 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected December 11, 2023.
Company Profile
This profile covers Westlake IVF, LLC based in Austin, Texas, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 4
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 1
First inspected July 5, 2012. Last inspected December 11, 2023.
Most cited issue areas
- Eligibility not required--warning labels4 inspections
- Responsible person to determine, document4 inspections
- Risk factors, clinical evidence4 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2023 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1224705 |
| April 1, 2021 | VAI | Biologics · Vaccines and Allergenic Products | 1137433 |
| May 31, 2019 | OAI | Biologics · Blood and Blood Products | 1091290 |
| March 31, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 920275 |
| July 5, 2012 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 789421 |
FDA documents
Form 483s (2)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Westlake IVF, LLC
FEI Number
3009085684
Address
300 Beardsley Ln Bldg B Ste 200, Austin, Texas 78746, United States
Country
United States
ID: 8bda4bbc-0ea0-47c3-aebc-9452f4202a7c