FDA clears Nephros after 2015 warning letter

Nephros (OTC:NEPH) said last week it received a notice from the FDA closing out a warning letter the company received last May concerning issues with the manufacturing of a variety of its filtration systems.

The warning from the federal watchdog to River Edge, N.J.-based Nephros included warnings on a failure to document and evaluate potential suppliers and a failure to include required information in records and complaint investigations.

Nephros responded to the initial warning letter and received a response from the FDA in August outlining what corrective actions would be required.

The company said the FDA indicated it would verify Nephros’ implementation of corrective measures on its next inspection.

Nephros noted that the initial warning letter and subsequent letter did not restrict its ability to manufacture, produce or ship its products, and did not require any recalls.

After a follow-up inspection in February this year, the FDA was able to clear the company, according to an SEC filing.

In October 2013, Nephros saw shares plummeted nearly 68% after it issued a recall of 3 of its in-line ultrafilters after receiving reports of bacterial contamination that may have led to a patient’s death.

Nephros said it received reports about its SafeSpout and SafeShower point-of-use filters from 1 customer of “high bacterial counts” likely due to “the breakage of fiber in 4 filters” that may have led to the death and to another instance of infection, according to a regulatory filing

The company logged another 29 complaints of high bacterial counts that were not associated with any adverse events, according to the filing.

The post FDA clears Nephros after 2015 warning letter appeared first on MassDevice.

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