Teleflex hit with FDA warning letter over respiratory devices

The FDA has handed a warning letter to Teleflex ($TFX), citing manufacturing issues at an Illinois plant that produces nebulizers, humidifiers and other respiratory technologies. In its letter, the agency details a host of problems with the company's corrective actions, process verification and self-inspections. Following an earlier FDA visit, Teleflex submitted a list of fixes, but the agency found them inadequate, and now the firm has 15 days to address the violations. Letter

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