Xellia Pharmaceuticals USA LLC
Form 483 issued December 15, 2022 · Bedford, Ohio
- Inspection
- Nov 28 – Dec 15, 2022
- Investigators
- Lisa R. Hilliard· Nibin Varghese· Vaishali J. Patel
- Observations
- 5
- Pages
- 5
- FEI number
- 3012279857
In short: On December 15, 2022, FDA issued a Form 483 with 5 observations to Xellia Pharmaceuticals USA LLC in Bedford, Ohio (FEI 3012279857) after an inspection that ran Nov 28 – Dec 15, 2022. The investigators were Lisa R. Hilliard, Nibin Varghese and Vaishali J. Patel. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xellia Pharmaceuticals USA LLC?
FDA listed 5 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Xellia Pharmaceuticals USA LLC?
Lisa R. Hilliard, Nibin Varghese and Vaishali J. Patel are named on this Form 483, for the inspection of Nov 28 – Dec 15, 2022. Each investigator has a profile showing what they cite most.
When was Xellia Pharmaceuticals USA LLC inspected by FDA?
The inspection ran Nov 28 – Dec 15, 2022, and the Form 483 is dated December 15, 2022.
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.