|
|
Article: Baxter inspections shows give-and-take with FDA.(Baxter Healthcare)(Brief Article)
- Article from:
- Inspection Monitor
- Article date:
- June 1, 1997
CopyrightCOPYRIGHT 1997 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)
|
Baxter Health Care, Carolina, PR, San Juan District.
An inspection of Baxter Health Care's parenteral drug plant in Carolina, PR, shows how FDA will back down when a company is dogged and defends its actions based on science.
Baxter's response to the 16-item 483 following a July-August 1995 inspection, for which records were recently released, "produced the desired results," a company spokesperson or spokesman said. Two months later, the firm received notification from the agency that it was satisfied, she or He said.
Half of the 483 citations concerned water for injection (WFI) systems and use of media fills, PR. FDA also hit computer security, ...