FDA 483 - Covance Laboratories, Inc. - November 02, 2000
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An FDA inspection of Covance Laboratories, Inc. in Vienna, VA, a non-clinical laboratory, revealed significant issues related to study conduct and data integrity. Observations included the failure to review clinical history records, leading to the inclusion of Hepatitis A positive animals in a study, and inaccuracies in the final report regarding animal testing. Additionally, the firm failed to include dosage formulation analyses in a final report and exhibited poor record-keeping for protocol amendments and equipment documentation.
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