Bose CorporationNovember 12, 2021

FDA 483 - Bose Corporation - November 12, 2021

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Record Details

Bose Corporation in Framingham, MA, underwent an FDA inspection of its manufacturing facility. The inspection revealed that procedures for device history records for its SoundControl Hearing Aids were not adequately established. This indicates a deficiency in the firm's quality system regarding documentation and recordkeeping.

Company: Bose Corporation
Inspection Date: November 12, 2021
Product Type: Device
Office: Division of Northeast Imports
Person: James P. Finn (investigator)

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ID · ddd75443-3016-4cf5-b285-7d447a801797