# FDA 483 - Delaware Institute for Reproductive Medicine, P.A - June 20, 2019

Source: https://www.globalkeysolutions.net/records/483/delaware-institute-for-reproductive-medicine-pa/904527b4-d732-4d05-b797-0c7f9d851ccc

> FDA 483 for Delaware Institute for Reproductive Medicine, P.A on June 20, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Delaware Institute for Reproductive Medicine, P.A
- Inspection Date: 2019-06-20
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: The FDA inspected Delaware Institute for Reproductive Medicine, P.A. in Newark, DE, from June 18-20, 2019, and issued a Form 483. The inspection revealed a significant deficiency in donor screening practices, specifically regarding the assessment of risk factors for Zika Virus in oocyte donors. This indicates a serious lapse in ensuring donor eligibility and preventing the transmission of communicable diseases.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/erika-m-wilkerson/cd1c299d-c827-4d52-8e2b-719989da9991)

Company: https://www.globalkeysolutions.net/companies/delaware-institute-for-reproductive-medicine-pa/15cecf6a-a321-4390-9048-921999542784

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