Company
United StatesStratus BioSystems, LLC, Grapevine, TX – FDA Inspections
Inspection records and compliance data for Stratus BioSystems, LLC in Grapevine, Texas. 2 FDA inspections on record (1 OAI), 2 warning letters, last inspected June 11, 2024.
Company Profile
This profile covers Stratus BioSystems, LLC based in Grapevine, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 2
First inspected November 10, 2021. Last inspected June 11, 2024.
Most cited issue areas
- Process validation procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2024 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1241211 |
| November 10, 2021 | OAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1157351 |
FDA documents
Form 483s (2)
- Form 483s · June 11, 2024
- Form 483s · November 10, 2021
Warning Letters (2)
Related Companies (10)
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Company Information
Name
Stratus BioSystems, LLC
FEI Number
3014171113
Address
913 S Main St Unit 215, Grapevine, Texas 76051, United States
Country
United States
ID: 19f91252-2572-4e95-af09-c6ab599ed544