Company
United StatesAlaris Biologic Technologies, Inc., Gainesville, FL – FDA Inspections
Inspection records and compliance data for Alaris Biologic Technologies, Inc. in Gainesville, Florida. 3 FDA inspections on record, 1 Form 483, last inspected March 02, 2018.
Company Profile
This profile covers Alaris Biologic Technologies, Inc. based in Gainesville, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 13, 2015. Last inspected March 2, 2018.
Most cited issue areas
- Changes to validated process2 inspections
- Quality audits performed periodically2 inspections
- Adequate control, proper conditions1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 2, 2018 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1042813 |
| April 29, 2016 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 987207 |
| May 13, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 926000 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Alaris Biologic Technologies, Inc.
FEI Number
3010898668
Address
3542 Nw 97th Blvd, Gainesville, Florida 32606, United States
Country
United States
ID: 7d9d6418-d831-4366-868c-560f1ff92452