# FDA 483 - Center for Fertility and Reproductive Endocrinology UPP - December 08, 2021

Source: https://www.globalkeysolutions.net/records/483/center-for-fertility-and-reproductive-endocrinology-upp/6a3fe83d-f04f-4ff0-bb01-c224fd427dc7

> FDA 483 for Center for Fertility and Reproductive Endocrinology UPP on December 08, 2021. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Center for Fertility and Reproductive Endocrinology UPP
- Inspection Date: 2021-12-08
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Center for Fertility and Reproductive Endocrinology UPP in Pittsburgh, PA, revealed deficiencies in donor screening practices. The firm failed to adequately screen donors for communicable disease risk factors due to an incomplete donor risk assessment questionnaire. Additionally, an ineligible donor with risk factors for communicable disease agents was determined eligible and transferred to a recipient.

## Related Officers

- [Jennifer L. Sheehan](https://www.globalkeysolutions.net/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)
- [Consumer Safety Officer/Investigator](https://www.globalkeysolutions.net/people/carl-e-lovrich/28ad3898-eaac-4f07-8dc5-09bda890c63a)

Company: https://www.globalkeysolutions.net/companies/center-for-fertility-and-reproductive-endocrinology-upp/6019ae52-373a-4b57-bc21-390f533bc8e7

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8