Company
United StatesAssureImmune, LLC, Miami, FL – FDA Inspections
Inspection records and compliance data for AssureImmune, LLC in Miami, Florida. 5 FDA inspections on record, last inspected January 15, 2026.
Company Profile
This profile covers AssureImmune, LLC based in Miami, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 16, 2009. Last inspected January 15, 2026.
Most cited issue areas
- Cell-associated CD1 inspection
- Controlling the labeling of HCT/Ps1 inspection
- Ensuring appropriate core requirements followed1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 15, 2026 | Not classified | Biologics | 1299120 |
| February 12, 2020 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1121360 |
| November 8, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1034907 |
| July 16, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 842553 |
| June 16, 2009 | VAI | Biologics · Blood and Blood Products | 590674 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
AssureImmune, LLC
FEI Number
3006813595
Address
1011 Sunnybrook Rd Ste 900, Miami, Florida 33136, United States
Country
United States
ID: cf87c738-a5eb-47ee-9654-ef46919254df