Company
United StatesCSL Plasma, Inc., Portland, OR – FDA Inspections
Inspection records and compliance data for CSL Plasma, Inc. in Portland, Oregon. 7 FDA inspections on record, 1 Form 483, last inspected October 21, 2022.
Company Profile
This profile covers CSL Plasma, Inc. based in Portland, Oregon, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected November 2, 2009. Last inspected October 21, 2022.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Equipment observed, standardized, calibrated1 inspection
- Following manufacturer's instructions1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 21, 2022 | NAI | Biologics · Blood and Blood Products | 1182014 |
| October 26, 2017 | VAI | Biologics · Blood and Blood Products | 1029879 |
| February 19, 2016 | NAI | Biologics · Blood and Blood Products | 961840 |
| March 5, 2014 | NAI | Biologics · Blood and Blood Products | 868764 |
| January 17, 2012 | VAI | Biologics · Blood and Blood Products | 764129 |
| September 2, 2011 | VAI | Biologics · Blood and Blood Products | 744589 |
| November 2, 2009 | NAI | Biologics · Blood and Blood Products | 625492 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CSL Plasma, Inc.
FEI Number
3022511
Address
16225 Ne Glisan St, Portland, Oregon 97230, United States
Country
United States
ID: 659b5c4a-dc87-4b3c-91f7-91ba40dd6470