Patheon Biologics Australia Pty Ltd.
FDA inspection history in Woolloongabba, Australia, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Woolloongabba, Australia.
Cited most
Across all Patheon Biologics Australia Pty observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Patheon Biologics Australia Pty file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Woolloongabba, Australia
One Form 483 · 2023 · 2 observations
Latest: Form 483, Oct 17, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-17 | 483 Form 483 | Woolloongabba, Australia | 2 | $99 |
Investigators on these documents
FEI number 3010976475 · most recent document Oct 17, 2023
About Patheon Biologics Australia Pty Ltd.
How many FDA Form 483s has Patheon Biologics Australia Pty Ltd. received?
FDA Intel has 1 Form 483 on file for Patheon Biologics Australia Pty Ltd.; the most recent is dated Oct 17, 2023.
When was Patheon Biologics Australia Pty Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Patheon Biologics Australia Pty Ltd. is a Form 483 dated Oct 17, 2023, for the site in Woolloongabba, Australia.
What did FDA cite at Patheon Biologics Australia Pty Ltd.?
The regulations cited most in the observations on file for Patheon Biologics Australia Pty Ltd. are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.