# FDA 483 - Winfield Laboratories, Inc. - September 25, 2018

Source: https://www.globalkeysolutions.net/records/483/winfield-laboratories-inc/35aac3fe-d22a-4b23-b67d-8e27701fdba9

> FDA 483 for Winfield Laboratories, Inc. on September 25, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Winfield Laboratories, Inc.
- Inspection Date: 2018-09-25
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Winfield Laboratories, Inc., a medical device manufacturer in Richardson, TX, revealed significant deficiencies across its quality system. The firm lacked established procedures and documentation for critical areas including design control, document control, management review, and quality audits. These issues indicate a fundamental breakdown in the firm's ability to ensure product quality and regulatory compliance.

## Related Officers

- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/winfield-laboratories-inc/773e28b7-0bcb-457c-b13a-e2f1b20cccd6

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