C. R. Bard, Inc. Discloses FDA Warning Letter Over IVC Filter Retrievers
C.R. Bard (NYSE:BCR) today revealed that it received a warning letter from the FDA over problems found at a pair of plants that make devices to retrieve inferior vena cava filters.
The July 12 warning letter from the FDA’s Los Angeles office “specifically cites quality systems and medical device reporting observations relating to non-conformances” found during inspections at Bard plants in Glens Falls, N.Y., and Tempe, Ariz., the company said.
The safety bureau’s findings affect “appropriate market clearance or approval” for 2 models of Bard’s recovery cone removal systems, according to a Bard regulatory filing.
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The July 12 warning letter from the FDA’s Los Angeles office “specifically cites quality systems and medical device reporting observations relating to non-conformances” found during inspections at Bard plants in Glens Falls, N.Y., and Tempe, Ariz., the company said.
The safety bureau’s findings affect “appropriate market clearance or approval” for 2 models of Bard’s recovery cone removal systems, according to a Bard regulatory filing.
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