Tools, Technologies and Training for Healthcare Laboratories

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The FDA-Abbott Consent Decree

A $100,000,000 fine? What's up? The 1999 Abbott-FDA Consent Decree resulted in a such a hugh penalty because of a long standing failure to comply with FDA's Good Manufacturing Practices or Quality System Regulation. How does this affect you? Dr. Westgard explains how the Consent Decree should alert laboratories and manufacturers of the importance of an independent laboratory quality system that assures the quality of routine test results.

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