Company
AustraliaBaxter Laboratories Pty. Ltd., Boronia, Australia – FDA Inspections
Inspection records and compliance data for Baxter Laboratories Pty. Ltd. in Boronia. 2 FDA inspections on record, 1 Form 483, last inspected July 22, 2022.
Company Profile
This profile covers Baxter Laboratories Pty. Ltd. based in Boronia, Australia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected September 22, 2017. Last inspected July 22, 2022.
Most cited issue areas
- Computer control of master formula records2 inspections
- Annual visual exams of drug products1 inspection
- Calibration/Inspection/Checking not done1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 22, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1175043 |
| September 22, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1027816 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Baxter Laboratories Pty. Ltd.
FEI Number
3003945201
Address
1019 Mountain Hwy, Boronia, Australia
Country
Australia
ID: 4f07afb7-4f57-465e-a0fd-14dc07c2211c