The FDA citedd ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California.

According to the FDA investigators, the device manufacturer did not maintain procedures to ensure all complaints were processed uniformly and on time. The investigators reviewed 6,975 complaints and found 829 were open while 6,146 were closed. Of the closed complaints, 4,923, or eight in 10, took longer than the company’s goal for the time between opening and closure.

Investigators also found several environmental deficiencies in the facility’s clean room. The inspection found numerous personal fans creating multidirectional airflow in this area, which “nullifies any attempt to create a unidirectional air flow system,” according to the Form 483. Investigators found personal fans blowing horizontally across the work station at five locations, and intermittent forced hot air at five other locations, as well as another five areas with intermittent forced cold air.

The inspection also found the facility failed to submit an MDR within 30 days of being notified of information suggesting one of its products may have caused or contributed to death or serious injury. The FDA identified nine MDRs the firm filed late. The time it took the company to submit the reports ranged from 31 days to a full year.