Company
IrelandBaxter Healthcare S.A., Castlebar, Ireland – FDA Inspections
Inspection records and compliance data for Baxter Healthcare S.A. in Castlebar. 3 FDA inspections on record, 1 Form 483, last inspected December 12, 2022.
Company Profile
This profile covers Baxter Healthcare S.A. based in Castlebar, Ireland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected October 14, 2014. Last inspected December 12, 2022.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- Complaint Handling Procedure1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 12, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1208377 |
| February 6, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1039972 |
| October 14, 2014 | VAI | Human Drugs · Drug Quality Assurance | 907572 |
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
Baxter Healthcare S.A.
FEI Number
405
Address
Moneen Road, Castlebar, Ireland
Country
Ireland
ID: 027068ec-1edf-444c-aabb-c9da8dbf31f0