# FDA 483 - Wintech Medipro LLC - July 06, 2022

Source: https://www.keypedia.com/records/483/wintech-medipro-llc/228d94c3-4d8e-4306-a58d-55f8ac648b7d

> FDA 483 for Wintech Medipro LLC on July 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wintech Medipro LLC
- Inspection Date: 2022-07-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Wintech Medipro LLC, a manufacturer of Class 2 surgical masks in Katy, TX, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm failed to establish fundamental procedures across nearly all critical areas of medical device manufacturing, including complaint handling, MDRs, design control, CAPA, and process validation. This indicates a severe lack of a compliant quality management system.

## Related Documents

- [WARNING_LETTER - 2022-07-06](https://www.keypedia.com/records/warning_letter/wintech-medipro-llc/e3ffa1ee-91d3-4420-b2af-a547d349defb)
- [483 - 2023-05-22](https://www.keypedia.com/records/483/wintech-medipro-llc/bd9a9602-ecec-4976-b771-74b5497dfc0f)

## Related Officers

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

Company: https://www.keypedia.com/companies/wintech-medipro-llc/bd2c9883-82f8-41f4-a1d3-1be0c41541dd

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