FDA 483 - Curia New Mexico, LLC - March 20, 2020
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OSO BioPharmaceuticals Manufacturing, LLC (AMRI) in Albuquerque, NM, a parenteral drug manufacturer, was cited for two observations. The inspection revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products and in the completeness of investigation records for unexplained discrepancies, including particle and insect contamination. These issues indicate a moderate to severe risk to product quality and patient safety.
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