Company
United StatesXGen Pharmaceuticals DJB, Inc., Horseheads, NY – FDA Inspections
Inspection records and compliance data for XGen Pharmaceuticals DJB, Inc. in Horseheads, New York. 7 FDA inspections on record, 3 Form 483s, last inspected June 14, 2024.
Company Profile
This profile covers XGen Pharmaceuticals DJB, Inc. based in Horseheads, New York, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 6
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected July 20, 2011. Last inspected June 14, 2024.
Most cited issue areas
- Failure to develop written procedures4 inspections
- Complaint Handling Procedure2 inspections
- Incomplete patient information on ICSR2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 14, 2024 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 1233326 |
| August 22, 2019 | VAI | Human Drugs · Bioresearch Monitoring | 1100288 |
| June 22, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1056541 |
| February 16, 2018 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 1041478 |
| December 23, 2015 | VAI | Human Drugs · Drug Quality Assurance | 954335 |
| March 8, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 769993 |
| July 20, 2011 | NAI | Human Drugs · Drug Quality Assurance | 737575 |
FDA documents
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Company Information
Name
XGen Pharmaceuticals DJB, Inc.
FEI Number
3005548067
Address
300 Daniel Zenker Dr, Horseheads, New York 14845, United States
Country
United States
ID: 42cd8012-b30d-440e-b2c7-e0d2915c417a