Biogen U.S. Corporation
Form 483 issued August 26, 2022 · Morrisville, North Carolina
- Inspection
- Aug 15 – Aug 26, 2022
- Investigators
- Song Y. Lavalais· Veronica Fuentes
- Observations
- 1
- Pages
- 2
- FEI number
- 3010164829
In short: On August 26, 2022, FDA issued a Form 483 with 1 observation to Biogen U.S. Corporation in Morrisville, North Carolina (FEI 3010164829) after an inspection that ran Aug 15 – Aug 26, 2022. The investigators were Song Y. Lavalais and Veronica Fuentes. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Input to and output from related systems of formulas and records or data are…
This inspection in context
Song Y. Lavalais
5 documents · 2021–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biogen U.S. Corporation?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Biogen U.S. Corporation?
Song Y. Lavalais and Veronica Fuentes are named on this Form 483, for the inspection of Aug 15 – Aug 26, 2022. Each investigator has a profile showing what they cite most.
When was Biogen U.S. Corporation inspected by FDA?
The inspection ran Aug 15 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.
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.