Company
United StatesCSL Plasma Inc., Melrose Park, IL – FDA Inspections
Inspection records and compliance data for CSL Plasma Inc. in Melrose Park, Illinois. 5 FDA inspections on record, last inspected March 21, 2024.
Company Profile
This profile covers CSL Plasma Inc. based in Melrose Park, Illinois, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected December 8, 2009. Last inspected March 21, 2024.
Most cited issue areas
- Biological product deviation report1 inspection
- Donor identification system1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2024 | NAI | Biologics · Blood and Blood Products | 1232706 |
| September 14, 2018 | NAI | Biologics · Blood and Blood Products | 1071041 |
| June 14, 2016 | NAI | Biologics · Blood and Blood Products | 985193 |
| September 26, 2014 | NAI | Biologics · Blood and Blood Products | 898360 |
| December 8, 2009 | VAI | Biologics · Blood and Blood Products | 634606 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
CSL Plasma Inc.
FEI Number
3005601555
Address
1977 N Mannheim Rd, Melrose Park, Illinois 60160, United States
Country
United States
ID: 10d40f00-7e25-42d2-b7c0-0f98f1097427