Biogen U.S. Corporation
Form 483 issued October 17, 2023 · Morrisville, North Carolina
- Inspection
- Oct 5 – Oct 17, 2023
- Investigators
- Gene D. Arcy· Latorie S. Jones
- Observations
- 5
- Pages
- 10
- FEI number
- 3010164829
In short: On October 17, 2023, FDA issued a Form 483 with 5 observations to Biogen U.S. Corporation in Morrisville, North Carolina (FEI 3010164829) after an inspection that ran Oct 5 – Oct 17, 2023. The investigators were Gene D. Arcy and Latorie S. Jones. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmBiogen U.S. Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biogen U.S. Corporation?
FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Biogen U.S. Corporation?
Gene D. Arcy and Latorie S. Jones are named on this Form 483, for the inspection of Oct 5 – Oct 17, 2023. Each investigator has a profile showing what they cite most.
When was Biogen U.S. Corporation inspected by FDA?
The inspection ran Oct 5 – Oct 17, 2023, and the Form 483 is dated October 17, 2023.
How do I get the full Form 483 for Biogen U.S. Corporation?
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.