# FDA 483 - Delasco Inc - January 14, 2025

Source: https://www.globalkeysolutions.net/records/483/delasco-inc/e215401a-4401-4e73-94fe-bbb9a9bbe7c1

> FDA 483 for Delasco Inc on January 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delasco Inc
- Inspection Date: 2025-01-14
- Product Type: device
- Office Name: Dallas District Office
- Summary: Delasco, LLC, a medical device manufacturer and initial importer/distributor in Plano, TX, was inspected by the FDA. The inspection revealed significant deficiencies in its quality system, specifically regarding the lack of established and implemented procedures for Medical Device Reporting (MDR), complaint handling, corrective and preventive actions (CAPA), and finished device acceptance activities. These findings indicate a serious lack of fundamental quality system controls for medical devices.

## Related Officers

- [Katherine M. Thames](https://www.globalkeysolutions.net/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [issuing_officer](https://www.globalkeysolutions.net/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.globalkeysolutions.net/companies/delasco-inc/d0518b9c-e272-4d1c-bf7c-48fb184402b8

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9