# FDA 483 - Cooper Institute for Advanced Reproductive Medicine - October 29, 2025

Source: https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/f5dca815-8462-4505-869e-d3bd27baf30a

> FDA 483 for Cooper Institute for Advanced Reproductive Medicine on October 29, 2025. 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: 2025-10-29
- Product Type: biologics
- 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 10 observations during an inspection from October 14-29, 2025. The observations primarily concern significant deficiencies in donor eligibility determination, screening, testing, recordkeeping, and the establishment of required procedures for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), with several issues being repeat observations from a previous inspection. These findings indicate a lack of adequate controls to ensure the safety and quality of HCT/Ps.

## Related Documents

- [483 - 2021-07-19](https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/66dde249-8505-4a4d-9e04-e4d253f2f72c)
- [WARNING_LETTER - 2021-07-19](https://www.keypedia.com/records/warning_letter/cooper-institute-for-advanced-reproductive-medicine/6702d3f1-1114-4c6b-bc27-29c11c219b41)
- [483 - 2022-12-09](https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/9593851c-8051-4c29-9f1b-122aa7ab233e)
- [483 - 2023-11-16](https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/7781667f-1adf-42ef-be5c-df90023c96f1)
- [483 - 2023-11-16](https://www.keypedia.com/records/483/cooper-institute-for-advanced-reproductive-medicine/8d320260-916f-425c-ac7a-903304c5a01d)

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.keypedia.com/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

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

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