After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks.

FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a maker of  Class III medical device life vests, with a number of observations, including failure to document a corrective and preventative action program (CAPA); review, evaluate, and investigate complaints; adequately establish procedures for design validation; and develop, maintain, and implement electronic Medical Device Reports (eMDRs) to the agency.

(The eMDR Final Rule, requiring manufacturers and importers to submit eMDRs, was published Feb. 13, 2014. The requirements of this final rule will take effect Aug. 14, 2015.)

Zoll’s senior management was also singled out in the Sept. 23 warning letter for being unable to provide records of adequate attendance at management review meetings in 2013 and 2014.

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