# FDA 483 - Cooper Institute for Advanced Reproductive Medicine - November 16, 2023

Source: https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/7781667f-1adf-42ef-be5c-df90023c96f1

> FDA 483 for Cooper Institute for Advanced Reproductive Medicine on November 16, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cooper Institute for Advanced Reproductive Medicine
- Inspection Date: 2023-11-16
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The Cooper Institute for Advanced Reproductive Medicine in Houston, TX, received a Form FDA 483 with 11 observations following an inspection from November 13-16, 2023. The inspection revealed significant deficiencies in donor eligibility determination, screening, testing, labeling, record-keeping, and the establishment of required procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Several observations, including failures in donor screening, establishing procedures, and indelible records, were noted as repeat issues.

## 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 - 2022-12-09](https://www.globalkeysolutions.net/records/483/cooper-institute-for-advanced-reproductive-medicine/9593851c-8051-4c29-9f1b-122aa7ab233e)

## Related Officers

- [Michelle Paxon](https://www.globalkeysolutions.net/people/michelle-paxon/1748c593-7d85-4ede-a5f4-8c0a33c21d52)
- [Bobbi Miller](https://www.globalkeysolutions.net/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)

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