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FDA Dings Audina Hearing Instrument Over Complaints

Aug. 16, 2017

Audina Hearing Instrument of Longwood, Florida, 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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