# FDA 483 - Reprolife America, LLC - March 20, 2026

Source: https://www.keypedia.com/records/483/reprolife-america-llc/536ccca4-4bc2-4939-98a3-cfd6228e8cb8

> FDA 483 for Reprolife America, LLC on March 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reprolife America, LLC
- Inspection Date: 2026-03-20
- Product Type: device
- Office Name: Dallas District Office
- Summary: Reprolife America, LLC in Kingwood, TX, a medical device manufacturer, received a Form FDA 483 with 10 observations during an inspection from March 16-20, 2026. The inspection revealed widespread deficiencies in the firm's quality management system, including a lack of documented procedures for design control, process validation, risk management, complaint handling, traceability, and corrective actions. These systemic failures indicate a significant lack of control over the manufacturing of Vitrification Solution Sets and Warning Solution Sets, potentially impacting product quality and safety.

## Related Officers

- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/reprolife-america-llc/80daa217-7c91-4235-844e-5dc2b98fc96e

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