# FDA 483 - IVF Laboratory of Central Florida LLC - December 11, 2019

Source: https://www.globalkeysolutions.net/records/483/ivf-laboratory-of-central-florida-llc/59c42470-5e40-4340-907d-75d39b612c63

> FDA 483 for IVF Laboratory of Central Florida LLC on December 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IVF Laboratory of Central Florida LLC
- Inspection Date: 2019-12-11
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of A&M Endeavors, LLC, a reproductive tissue establishment in Winter Park, FL, revealed significant deficiencies in donor screening and record-keeping practices. The firm failed to adequately screen semen donors for communicable disease risk factors, maintain complete summaries of communicable disease test results, and establish required procedures for donor eligibility determination and HCT/P labeling. These issues indicate a lack of robust controls to ensure donor safety and product quality.

## Related Documents

- [483 - 2021-07-14](https://www.globalkeysolutions.net/records/483/ivf-laboratory-of-central-florida-llc/8dad4610-7e67-4830-8d0d-abaf597670d1)

## Related Officers

- [Lura Baquero](https://www.globalkeysolutions.net/people/lura-baquero/55dc6eb5-01d5-427e-a3ef-cc6ca35f3837)

Company: https://www.globalkeysolutions.net/companies/ivf-laboratory-of-central-florida-llc/a3ff8eb3-156c-47a7-9871-089f1f82f703

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6