Company
United StatesKEDPLASMA LLC, Gallup, NM – FDA Inspections
Inspection records and compliance data for KEDPLASMA LLC in Gallup, New Mexico. 4 FDA inspections on record, last inspected February 08, 2019.
Company Profile
This profile covers KEDPLASMA LLC based in Gallup, New Mexico, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected November 23, 2011. Last inspected February 8, 2019.
Most cited issue areas
- Adverse Reaction - Investigations1 inspection
- Donor reaction1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 8, 2019 | NAI | Biologics · Blood and Blood Products | 1081610 |
| November 30, 2017 | NAI | Biologics · Blood and Blood Products | 1037441 |
| November 20, 2015 | NAI | Biologics · Blood and Blood Products | 967775 |
| November 23, 2011 | VAI | Biologics · Blood and Blood Products | 756111 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
KEDPLASMA LLC
FEI Number
1627281
Address
1706 S Second St, Gallup, New Mexico 87301, United States
Country
United States
ID: f3f3364d-a117-4188-af10-a586451e385b