Company
AustraliaPhebra Pty Ltd, Lane Cove West, Australia – FDA Inspections
Inspection records and compliance data for Phebra Pty Ltd in Lane Cove West. 2 FDA inspections on record, 1 Form 483, last inspected October 22, 2019.
Company Profile
This profile covers Phebra Pty Ltd based in Lane Cove West, Australia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected October 27, 2017. Last inspected October 22, 2019.
Most cited issue areas
- Air filtration system lacking in production area1 inspection
- Calibration/Inspection/Checking not done1 inspection
- Cleaning SOPs/schedules1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 22, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1111930 |
| October 27, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1029998 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Phebra Pty Ltd
FEI Number
3007033408
Address
19 Orion Rd, Lane Cove West, Australia
Country
Australia
ID: 278cb6fd-9848-46bf-8b59-1733797275aa