CSL Behring (Australia) Pty Ltd.
Form 483 issued November 11, 2019 · Broadmeadows, Australia
- Inspection
- Nov 4 – Nov 11, 2019
- Investigators
- Gene D. Arcy· Scott Ballard· Yonggang Wang
- Observations
- 2
- Pages
- 3
- FEI number
- 3001644620
In short: On November 11, 2019, FDA issued a Form 483 with 2 observations to CSL Behring (Australia) Pty Ltd. in Broadmeadows, Victoria (FEI 3001644620) after an inspection that ran Nov 4 – Nov 11, 2019. The investigators were Gene D. Arcy, Scott Ballard and Yonggang Wang. Most observations concern production and biologics CGMP; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and biologics cgmp account for 2 of 2 observations.
Most cited: 21 CFR 211.110 (1×) · 600.14 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 02
Your firm has NOT submitted Biological Product Deviation Reports, in accordance with the SOP, Biological Product…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 211.110
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 2 observations on this Form 483, mostly about production and biologics CGMP. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected CSL Behring (Australia) Pty Ltd.?
Gene D. Arcy, Scott Ballard and Yonggang Wang are named on this Form 483, for the inspection of Nov 4 – Nov 11, 2019. Each investigator has a profile showing what they cite most.
When was CSL Behring (Australia) Pty Ltd. inspected by FDA?
The inspection ran Nov 4 – Nov 11, 2019, and the Form 483 is dated November 11, 2019.
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.