Xellia Pharmaceuticals USA LLC
Form 483 issued February 7, 2022 · Bedford, Ohio
- Inspection
- Jan 24 – Feb 7, 2022
- Investigators
- Andrew J. Barrowcliff· Lisa R. Hilliard
- Observations
- 1
- Pages
- 3
- FEI number
- 3012279857
In short: On February 7, 2022, FDA issued a Form 483 with 1 observation to Xellia Pharmaceuticals USA LLC in Bedford, Ohio (FEI 3012279857) after an inspection that ran Jan 24 – Feb 7, 2022. The investigators were Andrew J. Barrowcliff and Lisa R. Hilliard. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Andrew J. Barrowcliff
5 documents · 2018–2023
Cites 211.22(d) (responsibilities of quality control unit) 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(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xellia Pharmaceuticals USA LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Xellia Pharmaceuticals USA LLC?
Andrew J. Barrowcliff and Lisa R. Hilliard are named on this Form 483, for the inspection of Jan 24 – Feb 7, 2022. Each investigator has a profile showing what they cite most.
When was Xellia Pharmaceuticals USA LLC inspected by FDA?
The inspection ran Jan 24 – Feb 7, 2022, and the Form 483 is dated February 7, 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.