Company
United StatesOctapharma Plasma, Inc., Garland, TX – FDA Inspections
Inspection records and compliance data for Octapharma Plasma, Inc. in Garland, Texas. 4 FDA inspections on record, 1 Form 483, last inspected May 09, 2019.
Company Profile
This profile covers Octapharma Plasma, Inc. based in Garland, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected October 31, 2013. Last inspected May 9, 2019.
Most cited issue areas
- Adverse Reaction- Reports of Investigations1 inspection
- Donor Deferral - reentry1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 9, 2019 | VAI | Biologics · Blood and Blood Products | 1089185 |
| March 1, 2017 | NAI | Biologics · Blood and Blood Products | 1018343 |
| February 11, 2015 | NAI | Biologics · Blood and Blood Products | 913755 |
| October 31, 2013 | NAI | Biologics · Blood and Blood Products | 853429 |
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
Octapharma Plasma, Inc.
FEI Number
3008107480
Address
3342 Broadway Blvd Ste 110, Garland, Texas 75043, United States
Country
United States
ID: c384ed6f-a544-42af-8073-ae590af7c2c4