Company
United StatesKEDPlasma LLC, Williamsville, NY – FDA Inspections
Inspection records and compliance data for KEDPlasma LLC in Williamsville, New York. 6 FDA inspections on record, last inspected February 05, 2019.
Company Profile
This profile covers KEDPlasma LLC based in Williamsville, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected February 14, 2011. Last inspected February 5, 2019.
Most cited issue areas
- Concurrent documentation1 inspection
- Destruction of obsolete labels1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 5, 2019 | NAI | Biologics · Blood and Blood Products | 1079365 |
| May 7, 2018 | NAI | Biologics · Blood and Blood Products | 1053676 |
| November 10, 2015 | NAI | Biologics · Blood and Blood Products | 949234 |
| August 18, 2015 | NAI | Biologics · Blood and Blood Products | 941128 |
| December 5, 2012 | VAI | Biologics · Blood and Blood Products | 810579 |
| February 14, 2011 | NAI | Biologics · Blood and Blood Products | 711005 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
KEDPlasma LLC
FEI Number
1377602
Address
15 Limestone Dr, Williamsville, New York 14221, United States
Country
United States
ID: c96bce41-c33e-49df-a8bb-4c99d595d120