Company
AustraliaBaxter Healthcare Pty Ltd, Old Toongabbie, Australia – FDA Inspections
Inspection records and compliance data for Baxter Healthcare Pty Ltd in Old Toongabbie. 2 FDA inspections on record, 1 Form 483, last inspected July 05, 2022.
Company Profile
This profile covers Baxter Healthcare Pty Ltd based in Old Toongabbie, Australia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 9, 2019. Last inspected July 5, 2022.
Most cited issue areas
- Procedures for sterile drug products2 inspections
- Batch production and Batch Control Record Requirements1 inspection
- Complete test data included in records1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 5, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1173554 |
| April 9, 2019 | VAI | Human Drugs · New Drug Evaluation | 1085648 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Lyocontract GmbH
Kaysersberg Pharmaceuticals SAS
ENDO Pharmaceuticals Solutions, Inc.
Steriscience Specialties Private Limited
Patheon Italia S.p.A.
Amneal Oncology Private Limited
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
Ningbo Shuangcheng Pharmaceutical Co., Ltd
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
Steriscience SP. Z O.O.
Company Information
Name
Baxter Healthcare Pty Ltd
FEI Number
1000440083
Address
1 Baxter Dr, Old Toongabbie, Australia
Country
Australia
ID: a37e00b9-5cbd-4f45-922b-0f352f015507