Company
United StatesHaemoscope Division of Haemonetics Corp, Niles, IL – FDA Inspections
Inspection records and compliance data for Haemoscope Division of Haemonetics Corp in Niles, Illinois. 3 FDA inspections on record, last inspected April 15, 2016.
Company Profile
This profile covers Haemoscope Division of Haemonetics Corp based in Niles, Illinois, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 9, 2010. Last inspected April 15, 2016.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 15, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 968353 |
| May 24, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 834307 |
| September 9, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 680387 |
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
Haemoscope Division of Haemonetics Corp
FEI Number
2429444
Address
6231 W Howard St, Niles, Illinois 60714, United States
Country
United States
ID: ec0a5872-b68a-4fe8-88e1-25330aae1ee2