CSL Behring (Australia) Pty Ltd.
FDA inspection history in Broadmeadows, Australia, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Broadmeadows, Australia.
- 2024One Form 483, at Broadmeadows, Australia.
- 2024The longest 483 on file: 4 observations over 3 pages at Broadmeadows, Australia.
Cited most
Across all CSL Behring (Australia) Pty observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
The complete CSL Behring (Australia) Pty file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Broadmeadows, Australia
Two Form 483s · 2019 to 2024 · 6 observations
Latest: Form 483, Mar 8, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-08 | 483 Form 483 | Broadmeadows, Australia | 4 | $99 |
| 2019-11-11 | 483 Form 483 | Broadmeadows, Australia | 2 | $99 |
Investigators on these documents
Arnold Seo (1)Gene D. Arcy (1)Lei Zhang (1)Madushini Dharmasena (1)Scott Ballard (1)Yonggang Wang (1)
FEI number 3001644620 · most recent document Mar 8, 2024
About CSL Behring (Australia) Pty Ltd.
How many FDA Form 483s has CSL Behring (Australia) Pty Ltd. received?
FDA Intel has 2 Form 483s on file for CSL Behring (Australia) Pty Ltd.; the most recent is dated Mar 8, 2024.
When was CSL Behring (Australia) Pty Ltd. last inspected by FDA?
The most recent FDA inspection document on file for CSL Behring (Australia) Pty Ltd. is a Form 483 dated Mar 8, 2024, for the site in Broadmeadows, Australia.
What did FDA cite at CSL Behring (Australia) Pty Ltd.?
The regulations cited most in the observations on file for CSL Behring (Australia) Pty Ltd. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.