# FDA 483 - Fertility Center of San Antonio - May 24, 2021

Source: https://www.keypedia.com/records/483/fertility-center-of-san-antonio/c998b312-1e76-4f65-b269-71d50d1f6a42

> FDA 483 for Fertility Center of San Antonio on May 24, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fertility Center of San Antonio
- Inspection Date: 2021-05-24
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The FDA inspected Fertility Center of San Antonio and issued a Form 483 with two observations related to donor screening and record-keeping for reproductive tissues. The firm failed to adequately screen donors for communicable disease risks, specifically Zika Virus, by not including necessary questions on donor questionnaires. Additionally, their eligibility summary forms for HCT/Ps lacked a required statement confirming that communicable disease testing was performed by a CLIA-certified laboratory.

## Related Officers

- [investigator](https://www.keypedia.com/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.keypedia.com/companies/fertility-center-of-san-antonio/1e155ff5-4486-4135-acfe-726d0273b064

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab