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Article: FDA tips Abbott to next target in a future audit.
- Article from:
- Inspection Monitor
- Article date:
- May 1, 1998
CopyrightCOPYRIGHT 1998 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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Abbott Labs, Rocky Mount, NC, Atlanta District.
A preapproval audit of Abbott Labs' plant in Rocky Mount, NC, ended without a 483, but with a heads-up on what FDA might aim at during the next inspection.
Investigator Robert Lewis conducted the inspection in May 1997 for abbreviated new drug applications that were pending at the Center for Drugs. Twelve days later, the same plant underwent a Center for Biologics-directed audit of its plasma fractionating operations (See page 9).
The EIR said Lewis addressed "failure investigations, non-conforming materials, labeling and packaging procedures, annual reviews, complaints, sterilization ...