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.
Westone Laboratories’ medical device reporting compliance procedure stated that all complaints involving hearing protection products would be evaluated by the compliance manager to determine if an investigation was necessary. Yet the FDA investigator did not find evidence of this being implemented in any of the reviewed records.
The agency found that the firm did not have a management representative with the authority to ensure the satisfaction of quality system requirements. A quality unit responsible for implementing quality systems regulations was found to be lacking as well.
Cleaning and equipment maintenance schedules were also not fully or adequately established at the time of the FDA’s visit. The investigator revealed that preventative maintenance of facility ovens used in the manufacturing of hearing protection devices was discontinued in March 2017, and the last calibration conducted for oven thermometers was conducted in November 2014.