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Article: BLOOD & BIOLOGICS: 6902W
- Article from:
- Warning Letter Bulletin
- Article date:
- September 28, 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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Epitope, Beaverton, OR, June 22 (Office of Regional Operations). In a six-page warning letter, FDA cited failure to perform stability-related bioburden analyses or periodic preservative effectiveness testing for HIV-1 Western Blot Kit components and controls; failure to include lot release panels on a stability program, despite reports that panel degrada-tion caused some kits not to meet release requirements; and a lack of data to support the five-year shelf life established for processed serum/plasma or HIV-1 bulk serum controls. Further issues involved validation deficiencies related to mix times and cleaning; problems with environmental controls; inadequate sampling of ...