Company
United StatesGeneXtend, LLC, New York, NY – FDA Inspections
Inspection records and compliance data for GeneXtend, LLC in New York, New York. 2 FDA inspections on record, 1 Form 483, last inspected September 13, 2023.
Company Profile
This profile covers GeneXtend, LLC based in New York, New York, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 17, 2018. Last inspected September 13, 2023.
Most cited issue areas
- Responsible person to determine, document1 inspection
- Risk factors, clinical evidence1 inspection
- Testing, screening, donor eligibility procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2023 | NAI | Biologics · Blood and Blood Products | 1217689 |
| August 17, 2018 | VAI | Biologics · Blood and Blood Products | 1062807 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GeneXtend, LLC
FEI Number
3013598802
Address
423 W 127th St, New York, New York 10027, United States
Country
United States
ID: efa8624c-2ecb-4d56-804e-f40847f55404