# FDA 483 - IVF Laboratory of Central Florida LLC - July 14, 2021

Source: https://www.keypedia.com/records/483/ivf-laboratory-of-central-florida-llc/8dad4610-7e67-4830-8d0d-abaf597670d1

> FDA 483 for IVF Laboratory of Central Florida LLC on July 14, 2021. 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: 2021-07-14
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: A&M Endeavors, LLC, a reproductive tissue establishment in Winter Park, FL, was cited for significant deficiencies in donor screening and eligibility determination processes. The inspection revealed failures to adequately screen donors for communicable diseases, properly document donor eligibility, and maintain complete records of communicable disease test results. Additionally, the firm lacked established procedures for donor testing and screening, with some issues being repeat observations from a previous inspection.

## Related Documents

- [483 - 2019-12-11](https://www.keypedia.com/records/483/ivf-laboratory-of-central-florida-llc/59c42470-5e40-4340-907d-75d39b612c63)

## Related Officers

- [Lura Baquero](https://www.keypedia.com/people/lura-baquero/55dc6eb5-01d5-427e-a3ef-cc6ca35f3837)
- [Douglas Florentino](https://www.keypedia.com/people/douglas-florentino/97ac0438-05a2-42ee-91cc-80ae4a798d09)

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

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