Xellia Pharmaceuticals USA LLC
Form 483 issued September 29, 2023 · Bedford, Ohio
- Inspection
- Sep 19 – Sep 29, 2023
- Investigators
- Alan M. Barker· Nicholas J. Presto
- Observations
- 2
- Pages
- 4
- FEI number
- 3012279857
In short: On September 29, 2023, FDA issued a Form 483 with 2 observations to Xellia Pharmaceuticals USA LLC in Bedford, Ohio (FEI 3012279857) after an inspection that ran Sep 19 – Sep 29, 2023. The investigators were Alan M. Barker and Nicholas J. Presto. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmXellia Pharmaceuticals USA 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xellia Pharmaceuticals USA LLC?
FDA listed 2 observations on this Form 483, mostly about 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 Xellia Pharmaceuticals USA LLC?
Alan M. Barker and Nicholas J. Presto are named on this Form 483, for the inspection of Sep 19 – Sep 29, 2023. Each investigator has a profile showing what they cite most.
When was Xellia Pharmaceuticals USA LLC inspected by FDA?
The inspection ran Sep 19 – Sep 29, 2023, and the Form 483 is dated September 29, 2023.
How do I get the full Form 483 for Xellia Pharmaceuticals USA 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.