# FDA 483 - Oto Med Inc - August 30, 2024

Source: https://www.globalkeysolutions.net/records/483/oto-med-inc/9abc4605-ccd0-47aa-84d4-aa769db441d4

> FDA 483 for Oto Med Inc on August 30, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oto Med Inc
- Inspection Date: 2024-08-30
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Oto Med Inc, a medical device manufacturer in Lake Havasu City, AZ, revealed significant deficiencies across its quality system. Observations included inadequate documentation of corrective and preventive actions, poorly maintained complaint files, and insufficient procedures for device history records. Additionally, the firm failed to adequately validate processes, establish proper quality audit procedures, and ensure purchased products and services conformed to requirements.

## Related Officers

- [Scott D. Stevens](https://www.globalkeysolutions.net/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)

Company: https://www.globalkeysolutions.net/companies/oto-med-inc/d27c3fd7-fb36-4767-9684-7221a218c61a

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face