# FDA 483 - Cooper Institute for Advanced Reproductive Medicine - December 09, 2022

Source: https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/9593851c-8051-4c29-9f1b-122aa7ab233e

> FDA 483 for Cooper Institute for Advanced Reproductive Medicine on December 09, 2022. 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: 2022-12-09
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The Cooper Institute for Advanced Reproductive Medicine was cited for multiple deficiencies related to human reproductive tissue establishment operations. The inspection revealed failures in testing oocyte donors for communicable diseases like West Nile Virus, incomplete donor screening questionnaires, and inadequate record retention for HCT/Ps. Additionally, the firm lacked standard operating procedures for handling CMV-positive donors and for overall donor testing, screening, and eligibility determination.

## Related Documents

- [483 - 2021-07-19](https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/66dde249-8505-4a4d-9e04-e4d253f2f72c)
- [WARNING_LETTER - 2021-07-19](https://www.globalkeysolutions.net/records/warning_letter/cooper-institute-for-advanced-reproductive-medicine/6702d3f1-1114-4c6b-bc27-29c11c219b41)
- [483 - 2023-11-16](https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/7781667f-1adf-42ef-be5c-df90023c96f1)

## Related Officers

- [Gloria A. Milster](https://www.globalkeysolutions.net/people/gloria-a-milster/22f95276-6f68-467d-8d52-5c028c118123)

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