Device Distributor Nailed for Documentation Practices
A Waltham, Massachusetts medical device distributor was hit with a Form 483 over a lack of supplier documentation.
During its July 23-24, 2018 inspection, the FDA discovered Jali Medical didn’t document its supplier evaluations or records of approved suppliers. Specifically, the firm distributed various models of Class II magnetic stimulators without approving the supplier first.
“The president stated that there was no written agreement with [the] supplier to notify the firm of any changes to any of the Magstim magnetic stimulators,” the agency said.