CSL Behring (Australia) Pty Ltd.
Form 483 issued March 8, 2024 · Broadmeadows, Australia
- Inspection
- Feb 29 – Mar 8, 2024
- Investigators
- Arnold Seo· Lei Zhang· Madushini Dharmasena
- Observations
- 4
- Pages
- 3
- FEI number
- 3001644620
In short: On March 8, 2024, FDA issued a Form 483 with 4 observations to CSL Behring (Australia) Pty Ltd. in Broadmeadows, Victoria (FEI 3001644620) after an inspection that ran Feb 29 – Mar 8, 2024. The investigators were Arnold Seo, Lei Zhang and Madushini Dharmasena. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and production account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The manufacturing areas are not under control for mold. There is a high number of mold…
- 02
DS batch with major process deviation was released based…
- 03
The laboratory data management lacks adequate oversight and/or verification to assure the…
- 04
Written documents lack sufficiently detailed…
This inspection in context
Arnold Seo
1 document · 2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Australia.
The firmCSL Behring (Australia) Pty Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CSL Behring (Australia) Pty Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected CSL Behring (Australia) Pty Ltd.?
Arnold Seo, Lei Zhang and Madushini Dharmasena are named on this Form 483, for the inspection of Feb 29 – Mar 8, 2024. Each investigator has a profile showing what they cite most.
When was CSL Behring (Australia) Pty Ltd. inspected by FDA?
The inspection ran Feb 29 – Mar 8, 2024, and the Form 483 is dated March 8, 2024.
How do I get the full Form 483 for CSL Behring (Australia) Pty Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.