Company
United StatesHaemonetics Software Solutions, El Dorado Hills, CA – FDA Inspections
Inspection records and compliance data for Haemonetics Software Solutions in El Dorado Hills, California. 3 FDA inspections on record, 1 Form 483, last inspected March 21, 2017.
Company Profile
This profile covers Haemonetics Software Solutions based in El Dorado Hills, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 17, 2012. Last inspected March 21, 2017.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1005035 |
| February 13, 2014 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 866853 |
| August 17, 2012 | NAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 794970 |
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
Haemonetics Software Solutions
FEI Number
1000221345
Address
4925 Robert J Mathews Pkwy Ste 100, El Dorado Hills, California 95762, United States
Country
United States
ID: 1430c33c-dc06-46f8-8144-3db4978e3df7