CSL Behring LLC
Form 483 issued March 2, 2023 · Bradley, Illinois
- Inspection
- Feb 21 – Mar 2, 2023
- Investigators
- Brentley Collins· Unnee Ranjan
- Observations
- 6
- Pages
- 8
- FEI number
- 1410248
In short: On March 2, 2023, FDA issued a Form 483 with 6 observations to CSL Behring LLC in Bradley, Illinois (FEI 1410248) after an inspection that ran Feb 21 – Mar 2, 2023. The investigators were Brentley Collins and Unnee Ranjan. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 5 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Failure to submit a biological product deviation report within 45 days from the date you acquired…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Written procedures are not…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCSL Behring LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CSL Behring LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and biologics CGMP. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected CSL Behring LLC?
Brentley Collins and Unnee Ranjan are named on this Form 483, for the inspection of Feb 21 – Mar 2, 2023. Each investigator has a profile showing what they cite most.
When was CSL Behring LLC inspected by FDA?
The inspection ran Feb 21 – Mar 2, 2023, and the Form 483 is dated March 2, 2023.
How do I get the full Form 483 for CSL Behring LLC?
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.