# FDA 483 - Cabell Huntington Hospital dba Center for Reproductive Medicine - August 18, 2022

Source: https://www.globalkeysolutions.net/records/483/cabell-huntington-hospital-dba-center-for-reproductive-medicine/ec1a9f81-6324-4ebd-89a8-82d0385d6323

> FDA 483 for Cabell Huntington Hospital dba Center for Reproductive Medicine on August 18, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cabell Huntington Hospital dba Center for Reproductive Medicine
- Inspection Date: 2022-08-18
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Cabell Huntington Hospital dba Center for Reproductive Medicine in Huntington, WV, revealed significant deficiencies in its reproductive Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) program. The firm failed to use FDA-licensed tests for communicable disease agents in oocyte donors, did not test for relevant agents like West Nile Virus, and lacked proper screening for Zika Virus risk factors. Additionally, the facility did not establish and maintain adequate procedures for donor testing and screening.

## Related Officers

- [Consumer Safety Officer/Investigator](https://www.globalkeysolutions.net/people/carl-e-lovrich/28ad3898-eaac-4f07-8dc5-09bda890c63a)

Company: https://www.globalkeysolutions.net/companies/cabell-huntington-hospital-dba-center-for-reproductive-medicine/e38eb043-ae30-4eca-890e-4bfe53478c68

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64