FDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023
Form 483 issued September 8, 2023 · Dessau- Rossl au
- Inspection
- Aug 31 – Sep 8, 2023
- Investigators
- Laurel A. Beer· Roger F. Zabi Nski
- Observations
- 5
- Pages
- 5
- FEI number
- 3005001
In short: On September 8, 2023, FDA issued a Form 483 with 5 observations to FDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023 in Dessau- Rossl au (FEI 3005001) after an inspection that ran Aug 31 – Sep 8, 2023. The investigators were Laurel A. Beer and Roger F. Zabi Nski. Most observations concern facilities & equipment and biologics CGMP.
At a glance
Facilities & equipment and biologics cgmp account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 610.1
Lots of licensed products were released by the manufacturer prior to completion of tests for confonnity…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The suitability of all testing methods is not verified under…
- 04
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
The firmFDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023 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 FDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, biologics CGMP and laboratory controls. The opening words of each observation are shown on this page.
Who inspected FDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023?
Laurel A. Beer and Roger F. Zabi Nski are named on this Form 483, for the inspection of Aug 31 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was FDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023 inspected by FDA?
The inspection ran Aug 31 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for FDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023?
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.