Biogen Idec ($BIIB) has encountered its share of manufacturing headaches because of the multiple sclerosis drug Tysabri that it acquired from Elan ($ELN). It will now have to add to that list some limited FDA concerns over its API manufacturing.

According to a Form 483 posted Friday to the FDA website, inspectors during a 5-day visit in July noted a couple of problems with processes at the plant in North Carolina where Biogen makes the active pharmaceutical ingredients for both Tysabri and Avonex. Among other shortcomings, the FDA said Biogen Idec is too trusting with its supplier of the bulk bags used in the API closure system for Tysabri. The supplier certifies the bags are sterile and endotoxin free, but the FDA says Biogen has never once challenged or verified those results. Inspectors also noted Biogen was not logging information on some of the agents used in cleaning biosafety hoods in the Avonex production building or on surfaces in the Tysabri production building.

Biogen Idec spokesman Steven Goldsmith said in an email Monday that the Form 483 came out of the routine biennial inspection the plant went through. While there were the two observations, he said the "inspectors conveyed an overall positive impression of the quality systems and processes at this site." He said Biogen welcomes the feedback and has responded "with robust corrective actions which are currently in progress." The campus, which employs more than 1,100, not only makes the APIs for Tysabri and Avonex but also a number of products in clinical trials.

Labels: Tysabri