# FDA 483 - E2P4 Labs - September 17, 2024

Source: https://www.globalkeysolutions.net/records/483/e2p4-labs/326c5820-5c18-4143-8fbe-294bfc48cf24

> FDA 483 for E2P4 Labs on September 17, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: E2P4 Labs
- Inspection Date: 2024-09-17
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of E2P4 Labs, a reproductive firm in Plano, TX, revealed three observations related to deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly document donor eligibility determinations in summaries of records and lacked adequate written procedures for record retention and for determining donor eligibility. These findings indicate significant issues with the firm's quality system and compliance with HCT/P regulations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)
- [Ramon L. Gonzalez-Prieto](https://www.globalkeysolutions.net/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

Company: https://www.globalkeysolutions.net/companies/e2p4-labs/29ea74de-4cc8-41d4-aab4-7f5a7852334d

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