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A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of more than 100 people. [2] [3] [4] In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal ...
Product recalls are one of a number of corrective actions that can be taken for products that are deemed to be unsafe. [1] The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can cause significant legal costs. It can be difficult, if not impossible, to determine how costly can be ...
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Lorraine O'Grady (born September 21, 1934) is an American artist, writer, translator, and critic. Working in conceptual art and performance art that integrates photo and video installation, she explores the cultural construction of identity – particularly that of Black female subjectivity – as shaped by the experience of diaspora and hybridity.
FDA guidelines for companies to follow when recalling defective products under the Agency's jurisdiction are published in Title 21 of the Code of Federal Regulations, Part 7. These guidelines make clear that FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful.
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FDA warning letter. An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as: ... a correspondence that notifies regulated industry about violations that ...