FDA delivers Form 483 to Eisai plant in U.S.

An Eisai plant in Baltimore has been issued an FDA Form 483.

Japan’s Eisai, which has reduced its manufacturing operations in the U.S., is now facing regulatory concerns for a plant in Baltimore, Maryland.

The facility has received an FDA Form 483 with 5 observations for a both quality issues and data record keeping, FDA News reports.

The FDA cited the facility for failing to follow established drug testing procedures and it failure to take steps to fix problems in relation to test failures. It also cited the facility for not protecting data with single-use passwords to prevent analysts from having the ability to get into and delete sensitive data, a problem the FDA has cited a many other facilities.

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Eisai, which has been revamping some operations in the last few years in the face of generic competition, in 2015 stepped away from a manufacturing facility in North Carolina that it shared with Biogen. Biogen, which had been leasing an oral solid-dose operation in Research Triangle Park from Eisai, took over the rest of the plant, which included filling lines, taking on about 100 Eisai employees at the time. Several months later, facing its own cost pressures, Biogen cut about 130 jobs at the plant as part of a broader cost-cutting effort.


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