Inc. General Hearing Instruments

General Hearing Instruments, Inc..
Product: ready-wear-air conduction hearing aids
Date: 9/18/2013

This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC Section 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received your response letter, with enclosures, dated September 5, 2013, concerning our investigator?s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483), issued to you on August 15, 2013. We received your supplemental response, dated September 6, 2013, which noted your consult with Master Controls to review, counsel, and guide you in properly implementing the corrective actions. We address the responses below, in relation to each of the noted violations. The violations include, but are not limited to, the following:

2. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your complaint procedure does not designate a specific unit handling complaints. In addition, you document complaints in an electronic database; however, this is not addressed in your complaint procedure.

You explain the complaint procedure is integrated into the CAPA procedure. The CAPA procedure does not adequately explain the specific responsibilities and steps your firm will take to record, evaluate, and address the complaint.

3. Failure to adequately maintain your device master file, as required by 21 CFR 820.181. Specifically, you failed to include software specifications, quality assurance specifications, and packaging/labeling specifications for your hearing devices.

We agree with your proposed corrective action noted in item number 3.

FDA District Office: New Orleans District

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