AGC Biologics A/S
FDA inspection history in Soeborg, Denmark, 2019 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at Soeborg, Denmark.
- 2019The longest 483 on file: 8 observations over 4 pages at Soeborg, Denmark.
Cited most
Across all AGC Biologics A/S observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.188Batch production and control records1
The complete AGC Biologics A/S file.
All 2 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
Soeborg, Denmark
Two Form 483s · 2019 to 2021 · 10 observations
Latest: Form 483, May 10, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-05-10 | 483 Form 483 | Soeborg, Denmark | 2 | $99 |
| 2019-11-05 | 483 Form 483 | Soeborg, Denmark | 8 | $99 |
Investigators on these documents
Amy Hsu (1)Michael R. Shanks (1)Reyes Candau-Chacon (1)Riley Myers (1)Zhenzhen Liu (1)
FEI number 3004708748 · most recent document May 10, 2021
About AGC Biologics A/S
How many FDA Form 483s has AGC Biologics A/S received?
FDA Intel has 2 Form 483s on file for AGC Biologics A/S; the most recent is dated May 10, 2021.
When was AGC Biologics A/S last inspected by FDA?
The most recent FDA inspection document on file for AGC Biologics A/S is a Form 483 dated May 10, 2021, for the site in Soeborg, Denmark.
What did FDA cite at AGC Biologics A/S?
The regulations cited most in the observations on file for AGC Biologics A/S are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.