Eckert & Ziegler Radiopharma GmbH
FDA inspection history in Braunschweig, Germany, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Braunschweig, Germany.
Cited most
Across all Eckert & Ziegler Radiopharma observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?1
- 21 CFR 820.184Device history record1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.30Design controls1
The complete Eckert & Ziegler Radiopharma file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Braunschweig, Germany
One Form 483 · 2022 · 6 observations
Latest: Form 483, Jul 7, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-07 | 483 Form 483 | Braunschweig, Germany | 6 | $99 |
Investigators on these documents
FEI number 3007887641 · most recent document Jul 7, 2022
About Eckert & Ziegler Radiopharma GmbH
How many FDA Form 483s has Eckert & Ziegler Radiopharma GmbH received?
FDA Intel has 1 Form 483 on file for Eckert & Ziegler Radiopharma GmbH; the most recent is dated Jul 7, 2022.
When was Eckert & Ziegler Radiopharma GmbH last inspected by FDA?
The most recent FDA inspection document on file for Eckert & Ziegler Radiopharma GmbH is a Form 483 dated Jul 7, 2022, for the site in Braunschweig, Germany.
What did FDA cite at Eckert & Ziegler Radiopharma GmbH?
The regulations cited most in the observations on file for Eckert & Ziegler Radiopharma GmbH are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.52 (If I am a manufacturer, what information must I submit in my individual adverse event reports?), 1 time; 21 CFR 820.184 (Device history record), 1 time.