# FDA 483 - Cooper Institute for Advanced Reproductive Medicine - July 19, 2021

Source: https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/66dde249-8505-4a4d-9e04-e4d253f2f72c

> FDA 483 for Cooper Institute for Advanced Reproductive Medicine on July 19, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cooper Institute for Advanced Reproductive Medicine
- Inspection Date: 2021-07-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The Cooper Institute in Houston, TX, received a Form FDA 483 citing significant deficiencies in its human reproductive tissue establishment operations. Observations included failures in screening and testing donors for communicable disease risks like Zika and West Nile viruses, and a lack of proper documentation for physical examinations and donor eligibility. The firm also failed to establish written procedures for donor eligibility and to label non-compliant HCT/Ps with required warning statements.

## Related Documents

- [WARNING_LETTER - 2021-07-19](https://www.globalkeysolutions.net/records/warning_letter/cooper-institute-for-advanced-reproductive-medicine/6702d3f1-1114-4c6b-bc27-29c11c219b41)
- [483 - 2022-12-09](https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/9593851c-8051-4c29-9f1b-122aa7ab233e)
- [483 - 2023-11-16](https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/7781667f-1adf-42ef-be5c-df90023c96f1)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/darla-j-christopher/64d3f47f-f3c0-4cfd-a3e8-4dc0e69d04bd)

Company: https://www.globalkeysolutions.net/companies/cooper-institute-for-advanced-reproductive-medicine/cd9a1da8-2714-4af0-9d40-c7bdb827234c

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