# FDA 483 - Bose Corporation - November 12, 2021

Source: https://www.keypedia.com/records/483/bose-corporation/ddd75443-3016-4cf5-b285-7d447a801797

> FDA 483 for Bose Corporation on November 12, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bose Corporation
- Inspection Date: 2021-11-12
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/bose-corporation/4d2c84b9-68ea-4d10-8749-e4278178dca4

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94