# FDA 483 - Reproductive Health Center - February 06, 2019

Source: https://www.keypedia.com/records/483/reproductive-health-center/511d3e89-ab11-489e-838d-59f18eb8b334

> FDA 483 for Reproductive Health Center on February 06, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reproductive Health Center
- Inspection Date: 2019-02-06
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: During an inspection, the FDA observed that Reproductive Health Center in Tucson, AZ, failed to establish procedures for HCT/P donor screening, specifically for Zika Virus. Additionally, the firm did not maintain complete documentation of donor screening results for communicable diseases. These issues indicate deficiencies in their quality system for human reproductive tissue.

## Related Officers

- [Bryce A. May](https://www.keypedia.com/people/bryce-a-may/39683196-5fff-4608-808c-7f10df606f7b)

Company: https://www.keypedia.com/companies/reproductive-health-center/a9ce2697-f8c3-4969-9223-b1d2683c8e62

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6