|
|
Article: BioGenex Labs, San Ramon, CA, July 27 (San Francisco).(MEDICAL DEVICES)
- Article from:
- Warning Letter Bulletin
- Article date:
- August 1, 2006
CopyrightCOPYRIGHT 2006 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)
|
During an FDA investigation of BioGenex conducted from Feb. 1 through March 9, the agency determined that the manufacturer of pathology related stains, antibodies and in vitro diagnostic test kits was not in conformance with current GMP requirements of QS regulations for medical devices. Significant deviations included, but were not limited to the following.
BioGenex was cited for failure of management with executive responsibility to ensure that an adequate and effective QS had been fully implemented and maintained at all levels of the organization; failure to control products that did not conform to specifications; failure to establish procedures for the ...