FDANews
The QMN Weekly Bulletin

FDA Finds Shortfalls at Audina Plant

Aug. 18, 2017

A Florida hearing-aid manufacturer drew the FDA’s attention for various deficiencies observed during a May inspection, including inadequate procedures for responding to problems and complaints.

The agency said the company, Audina Hearing Instrument, of Longwood, did not include verification requirements to ensure corrective actions were effective in responding to problems and did not designate a specific unit in the company to handle complaints.

The agency also observed hearing-aid components stored in open anti-static bags, and employees working in an assembly area without wearing the wrist straps required by the company’s written instructions.

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