Eckert & Ziegler Radiopharma GmbH
Form 483 issued August 23, 2019 · Berlin, Germany
- Inspection
- Aug 19 – Aug 23, 2019
- Investigator
- Jose A. Cruz-Gonzalez
- Observations
- 13
- Pages
- 4
- FEI number
- 3005746948
In short: On August 23, 2019, FDA issued a Form 483 with 13 observations to Eckert & Ziegler Radiopharma GmbH in Berlin, Germany (FEI 3005746948) after an inspection that ran Aug 19 – Aug 23, 2019. The investigator was Jose A. Cruz-Gonzalez. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 11 of 13 observations.
Most cited: 21 CFR 211.42 (6×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmEckert & Ziegler Radiopharma GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eckert & Ziegler Radiopharma GmbH?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Eckert & Ziegler Radiopharma GmbH?
Jose A. Cruz-Gonzalez is named on this Form 483, for the inspection of Aug 19 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Eckert & Ziegler Radiopharma GmbH inspected by FDA?
The inspection ran Aug 19 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
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.