FDA Faults Biogen Over Sterility, 'Questionable' Paperwork

Law360, New York (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...
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