Biogen International GmbH
Form 483 issued March 29, 2022 · Luterbach, Switzerland
- Inspection
- Mar 21 – Mar 29, 2022
- Investigators
- Leiyun Boone· Richard Ledwidge
- Observations
- 4
- Pages
- 2
- FEI number
- 3017081436
In short: On March 29, 2022, FDA issued a Form 483 with 4 observations to Biogen International GmbH in Luterbach, Solothurn (FEI 3017081436) after an inspection that ran Mar 21 – Mar 29, 2022. The investigators were Leiyun Boone and Richard Ledwidge. Most observations concern production and materials.
At a glance
Production and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Vendor qualification for raw…
- 02
Documentation and traceability of the use of reference…
- 03
There is inadequate assurance that{fPusea in (ares substance manufacturing process…
- 04
The microbial validation data to support the allowab ee operation into a…
This inspection in context
Leiyun Boone
8 documents · 2021–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
The firmBiogen International GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biogen International GmbH?
FDA listed 4 observations on this Form 483, mostly about production, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Biogen International GmbH?
Leiyun Boone and Richard Ledwidge are named on this Form 483, for the inspection of Mar 21 – Mar 29, 2022. Each investigator has a profile showing what they cite most.
When was Biogen International GmbH inspected by FDA?
The inspection ran Mar 21 – Mar 29, 2022, and the Form 483 is dated March 29, 2022.
How do I get the full Form 483 for Biogen International 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.