FDA Flags Quality and Calibration Issues at Earpiece Manufacturing Facility

Westone Laboratories’ manufacturing facility in Oregon drew a Form 483 from the FDA for significant quality system nonconformities and equipment calibration issues.

A November 2017 inspection revealed the firm’s quality system had deficiencies in all 11 costumer complaint records reviewed by the agency investigator.

In addition, the firm’s recordkeeping made it unclear if the issues described in the complaints represented adverse events that should have been reported to the FDA, and the efficiency of the its complaint processing could not be determined from the data on record, the agency said.