Xellia Pharmaceuticals USA LLC
FDA inspection history in Bedford, Ohio, 2022 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2022: two Form 483s; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Three Form 483s, at Bedford, Ohio.
- 2022The longest 483 on file: 5 observations over 5 pages at Bedford, Ohio.
Cited most
Across all Xellia Pharmaceuticals USA observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 111
- 21 CFR 211.100Written procedures; deviations1
The complete Xellia Pharmaceuticals USA file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bedford, Ohio
Three Form 483s · 2022 to 2023 · 8 observations
Latest: Form 483, Sep 29, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-29 | 483 Form 483 | Bedford, Ohio | 2 | $99 |
| 2022-12-15 | 483 Form 483 | Bedford, Ohio | 5 | $99 |
| 2022-02-07 | 483 Form 483 | Bedford, Ohio | 1 | $99 |
Investigators on these documents
Lisa R. Hilliard (2)Alan M. Barker (1)Andrew J. Barrowcliff (1)Nibin Varghese (1)Nicholas J. Presto (1)Vaishali J. Patel (1)
FEI number 3012279857 · most recent document Sep 29, 2023
About Xellia Pharmaceuticals USA LLC
How many FDA Form 483s has Xellia Pharmaceuticals USA LLC received?
FDA Intel has 3 Form 483s on file for Xellia Pharmaceuticals USA LLC; the most recent is dated Sep 29, 2023.
When was Xellia Pharmaceuticals USA LLC last inspected by FDA?
The most recent FDA inspection document on file for Xellia Pharmaceuticals USA LLC is a Form 483 dated Sep 29, 2023, for the site in Bedford, Ohio.
What did FDA cite at Xellia Pharmaceuticals USA LLC?
The regulations cited most in the observations on file for Xellia Pharmaceuticals USA LLC are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.