High Chemical Co

High Chemical Company, a division of National Generic Distributors, is a drug manufacturing facility located in Levittown, Pennsylvania. The company specializes in the production and distribution of active pharmaceutical ingredients (APIs) for various drugs. However, the facility has recently received a warning letter from the U.S. Food and Drug Administration (FDA) due to significant deviations from current good manufacturing practice (CGMP) for APIs. These deviations include the failure to conduct appropriate laboratory tests to determine conformance to specifications for each batch of API, as well as the lack of a documented, ongoing stability testing program. As a result, the FDA has deemed the company's APIs to be adulterated and has identified one of their drugs, Sarracenia Purpurea Sarapin Distillate, as misbranded.

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