Dendreon Pharmaceuticals LLC
FDA inspection history in Union City, Georgia, 2015 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2018: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Union City, Georgia.
- 2018One Form 483, at Union City, Georgia.
- 2022One Form 483, at Union City, Georgia.
- 2022The longest 483 on file: 3 observations over 4 pages at Union City, Georgia.
Cited most
Across all Dendreon Pharmaceuticals observations on file
- 21 CFR 211.198Complaint files2
- 21 CFR 123.7(d)Corrective actions1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.25Personnel qualifications1
The complete Dendreon Pharmaceuticals 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
Union City, Georgia
Three Form 483s · 2015 to 2022 · 7 observations
Latest: Form 483, Apr 21, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-04-21 | 483 Form 483 | Union City, Georgia | 3 | $99 |
| 2018-10-22 | 483 Form 483 | Union City, Georgia | 2 | $99 |
| 2015-01-09 | 483 Form 483 | Union City, Georgia | 2 | $99 |
Investigators on these documents
FEI number 3008914686 · most recent document Apr 21, 2022
About Dendreon Pharmaceuticals LLC
How many FDA Form 483s has Dendreon Pharmaceuticals LLC received?
FDA Intel has 3 Form 483s on file for Dendreon Pharmaceuticals LLC; the most recent is dated Apr 21, 2022.
When was Dendreon Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for Dendreon Pharmaceuticals LLC is a Form 483 dated Apr 21, 2022, for the site in Union City, Georgia.
What did FDA cite at Dendreon Pharmaceuticals LLC?
The regulations cited most in the observations on file for Dendreon Pharmaceuticals LLC are 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 123.7(d) (Corrective actions), 1 time; 21 CFR 211.160 (General requirements), 1 time.