Company
AustraliaAlphapharm Pty, Ltd., Carole Park, Australia – FDA Inspections
Inspection records and compliance data for Alphapharm Pty, Ltd. in Carole Park. 8 FDA inspections on record, last inspected June 28, 2024.
Company Profile
This profile covers Alphapharm Pty, Ltd. based in Carole Park, Australia.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 4
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected October 30, 2008. Last inspected June 28, 2024.
Most cited issue areas
- Procedure Deviations Recorded and Justified1 inspection
- Written procedures not established/followed1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1238748 |
| May 3, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1236816 |
| October 24, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1111818 |
| September 15, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1029077 |
| July 2, 2015 | NAI | Human Drugs · Drug Quality Assurance | 936225 |
| July 18, 2013 | VAI | Human Drugs · Drug Quality Assurance | 844498 |
| June 17, 2011 | VAI | Human Drugs · Drug Quality Assurance | 750363 |
| October 30, 2008 | VAI | Human Drugs · Drug Quality Assurance | 548507 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alphapharm Pty, Ltd.
FEI Number
3002806388
Address
15 Garnett St, Carole Park, Australia
Country
Australia
ID: 9007b3c5-9b83-4783-b65d-52eb0246708e