FDA Faults Biogen Over Sterility, 'Questionable' Paperwork

By Jeff Overley (December 9, 2013, 5:53 PM EST) -- Biogen Idec Inc. hasn't done enough to confirm the sterility of its containers and has repeatedly engaged in substandard recordkeeping, including one episode in which documentation was viewed by regulators as "questionable," according to a U.S. Food and Drug Administration inspection report released Friday.

In a so-called Form 483 that lists shortcomings at a North Carolina facility, the FDA dinged Biogen for allegedly failing to verify that certain containers supplied by third parties were free of bacterial toxins. Instead, the company accepted as true representations that bags used to store the multiple sclerosis drug Tysabri were contaminant-free, according to the FDA....

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Attached Documents

Related Sections

Companies

Government Agencies

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!