Eckert & Ziegler Radiopharma GmbH
Form 483 issued July 7, 2022 · Braunschweig, Germany
- Investigator
- Stephen D. Eich
- Observations
- 6
- Pages
- 56
- FEI number
- 3007887641
In short: On July 7, 2022, FDA issued a Form 483 with 6 observations to Eckert & Ziegler Radiopharma GmbH in Braunschweig, Niedersachsen (FEI 3007887641). The investigator was Stephen D. Eich. Most observations concern cAPA and design controls.
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design validation have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
The device history record does not demonstrate that the device was manufactured in accordance with…
- 04
Written MDR procedures have…
This inspection in context
Stephen D. Eich
6 documents · 2019–2025
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Illinois.
The firmEckert & Ziegler Radiopharma GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eckert & Ziegler Radiopharma GmbH?
FDA listed 6 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Eckert & Ziegler Radiopharma GmbH?
Stephen D. Eich is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Eckert & Ziegler Radiopharma GmbH inspected by FDA?
This Form 483 is dated July 7, 2022.
How do I get the full Form 483 for Eckert & Ziegler Radiopharma GmbH?
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.