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Article: Sage wiser after 7 audits, loss of lawsuit with FDA.(Sage Pharmaceuticals' manufacturing processes investigated by Food and Drug Administration)(Brief Article)
- Article from:
- Inspection Monitor
- Article date:
- May 1, 2000
CopyrightCOPYRIGHT 2000 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Sage Pharmaceuticals, Shreveport, LA, New Orleans District
According to general manager Bill Roche, contract manufacturer Sage Pharmaceuticals of Shreveport, LA, endured seven FDA inspections in 1999.
New Orleans district investigator Mark Rivero conducted all three inspections described in this article, leading Roche to comment that Rivero is the only FDA inspector with which the firm has had any experience.
The first inspection, which Rivero conducted on Feb. 12, 1999, filled out just over half a page on the 483. The first observation cited Sage for a protocol that fail to address the evaluation of a granulation drying process.
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