# FDA 483 - Lone Star Medical Products, Inc. - April 27, 2023

Source: https://www.keypedia.com/records/483/lone-star-medical-products-inc/376fd581-f97d-4100-ba84-6d82a6d88880

> FDA 483 for Lone Star Medical Products, Inc. on April 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lone Star Medical Products, Inc.
- Inspection Date: 2023-04-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Lone Star Medical Products, Inc. in Stafford, TX, was inspected and cited for significant deficiencies across its quality system. The inspection revealed issues with complaint investigations, software validation, design transfer, corrective and preventive actions, and incoming product acceptance. These findings indicate a systemic breakdown in ensuring product quality and compliance with established procedures.

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/lone-star-medical-products-inc/16f3ae83-de16-436d-a144-5d79b8660ec9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab