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Insanitary conditions and an environment that may not protect sterile products The FDA found that drug products intended to be sterile were prepared, packed, or held under insanitary conditions, rendering them adulterated under Section 501(a)(2)(A) of the FDCA

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Expression of Glutamine Synthetase and Carbamoylphosphate Synthetase I in a Bioartificial Liver: Markers for the Development of Zonation in vitro

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