Company
United StatesBaxalta US Inc., Westlake Village, CA – FDA Inspections
Inspection records and compliance data for Baxalta US Inc. in Westlake Village, California. 5 FDA inspections on record, last inspected September 09, 2015.
Company Profile
This profile covers Baxalta US Inc. based in Westlake Village, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected April 9, 2009. Last inspected September 9, 2015.
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 9, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 941459 |
| March 29, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 778289 |
| March 29, 2012 | NAI | Biologics · Bioresearch Monitoring | 774685 |
| May 13, 2010 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 661446 |
| April 9, 2009 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 576594 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Baxalta US Inc.
FEI Number
3000121413
Address
1 Baxter Way, Westlake Village, California 91362, United States
Country
United States
ID: bef7c778-60df-4ebe-97e6-a9b0c19a7c5c