Company
United StatesHemosphere, Inc. (A CryoLife, Inc. Company), Kennesaw, GA – FDA Inspections
Inspection records and compliance data for Hemosphere, Inc. (A CryoLife, Inc. Company) in Kennesaw, Georgia. 1 FDA inspection on record, 1 warning letter, last inspected February 14, 2014.
Company Profile
This profile covers Hemosphere, Inc. (A CryoLife, Inc. Company) based in Kennesaw, Georgia, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected February 14, 2014.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Documentation1 inspection
- Nonconforming product control1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 14, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 869118 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hemosphere, Inc. (A CryoLife, Inc. Company)
FEI Number
3010034761
Address
1655 Roberts Blvd NW, Kennesaw, Georgia 30144, United States
Country
United States
ID: dd991a1a-a84e-4526-bace-e0313f73924f