FDA: Company warned of contamination before outbreak | Synopsis

FDA: Company warned of contamination before outbreak

FDA Works to Lessen Drug Shortage Impact by The U.S. Food and Drug Administration
License (according to Flickr): United States Government Work

Excerpt:

(CNN) -- The company at the center of a deadly meningitis outbreak was warned by its own environmental monitors of bacterial contamination of its facility months before the first cases were reported, a government report said Friday. Mold, and in some cases, an overgrowth of bacteria was detected in different areas of the New England Compounding Center's two "clean rooms" nearly 90 times since January, the Food and Drug Administration report said. Clean rooms are intended to be sterile environments in which drugs are produced. FDA warns higher-risk patients amid meningitis outbreak Despite the warnings from its own monitors, the FDA report says the compounding center did not investigate the reports of the contamination nor is there documented evidence it worked to decontaminate the affected areas. Tainted medications from the compounding center have been blamed for the outbreak of fungal meningitis that has caused 25 deaths and 338 illnesses.

Concepts:

Bacteria Pharmacy Report Meningitis Pharmacist Corticosteroid Pharmacology Pharmaceutical drug

FDA: Company warned of contamination before outbreak

Additional Info:

Organization: New England Compounding Center

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Relevance: 0.865177

Organization: FDA

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Disambiguation: References:

• U.S. Food and Drug Administration: dbpedia
• U.S. Food and Drug Administration: opencyc

HealthCondition: meningitis

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Relevance: 0.781746

Disambiguation: DiseaseOrMedicalCondition | DiseaseReferences:

• Aseptic meningitis: dbpedia
• Aseptic meningitis: freebase
• Aseptic meningitis: umbel
• Aseptic meningitis: yago

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FDA: Company warned of contamination before outbreak

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The company at the center of a deadly meningitis outbreak was warned by its own environmental monitors of bacterial contamination of its facility months before the first cases were reported, a government report said Friday.

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