Complaint, Performance Problems Land Neuro-Fitness a 483

The FDA dinged device manufacturer Neuro-Fitness for complaint handling and ensuring device conformance.

The agency hit the company with a Form 483 following a July inspection of its Fall City, Wash., facility. According to investigators, the firm currently used an unapproved version of its complaint form that was missing sections on complaint investigation requirements, responses to complainants and required corrective actions.

Lastly, the firm’s procedure for purchasing controls required regular re-evaluation of suppliers for acceptability as well as for the company to keep an approved vendor list, but Neuro-Fitness failed to document re-evaluations or keep such a list.