Company
United StatesOctapharma Plasma Inc, Omaha, NE – FDA Inspections
Inspection records and compliance data for Octapharma Plasma Inc in Omaha, Nebraska. 6 FDA inspections on record, last inspected September 14, 2021.
Company Profile
This profile covers Octapharma Plasma Inc based in Omaha, Nebraska, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected August 28, 2009. Last inspected September 14, 2021.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs1 inspection
- Personnel capabilities1 inspection
- Person performing, test results, interpretation1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 14, 2021 | NAI | Biologics · Vaccines and Allergenic Products | 1153219 |
| March 24, 2017 | NAI | Biologics · Blood and Blood Products | 1009884 |
| January 8, 2015 | VAI | Biologics · Blood and Blood Products | 909240 |
| February 6, 2013 | NAI | Biologics · Blood and Blood Products | 820739 |
| June 7, 2011 | VAI | Biologics · Blood and Blood Products | 732180 |
| August 28, 2009 | NAI | Biologics · Blood and Blood Products | 608945 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Octapharma Plasma Inc
FEI Number
3006604254
Address
4411 Center St Ste B, Omaha, Nebraska 68105, United States
Country
United States
ID: 16e84dc9-eaf1-4e95-94c0-9e214ed2d5f1