Biogen Idec Gets 483 for Overlooking Particles

July 19, 2013

The FDA handed Biogen Idec’s Cambridge, Mass. facility a Form 483 after the company released a drug substance destined for compounding that contained white particles.

Biogen’s material review board recommended releasing the drug substance even though the lot contained particles later determined to be protein aggregates, the form reads.

The FDA called the board’s investigation “inadequate” because the cause of the particle formation was not determined, the particles hadn’t been seen before and “there was no clinical impact assessment of the presence of the white particles in the pooled drug substance.”

The lot was eventually released. Investigators discovered that the lot was not “put in the Biogen stability program for monitoring and evaluation…”

The drugmaker said it “provided a detailed response to the agency addressing the single observation issued during the March 2013 inspection with FDA. Indications from the inspectors at the end of the inspection were that the site maintained high quality processes and a high level of compliance.”

The drugmaker added that it welcomes input from the agency on how it can further improve processes and procedures that result in safe and effective products.

Biogen is not the only company to struggle with mystery particulates. Learn how to avoid manufacturing mistakes that earn warnings at FDA Compliance Boot Camp 2013 Validation, Quality and Compliance Training. Sign up to participate in the conference today.