# FDA 483 - Could You - July 11, 2024

Source: https://www.keypedia.com/records/483/could-you/339112e8-46d4-4414-825b-be172c2fd05f

> FDA 483 for Could You on July 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Could You
- Inspection Date: 2024-07-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Could You, a medical device manufacturer in Oceanside, CA, revealed deficiencies in their quality audit procedures. Specifically, the firm failed to adequately establish procedures for quality audits and did not maintain internal audit records as required by their own SOP. This indicates a moderate severity issue related to quality system compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/could-you/d51f7b05-abca-4ed9-abf4-90e29275449f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6