> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ‘Significant’ HCT/P Deviations at Cooper Institute
- URL: https://www.fdaweb.com/significant-hct-p-deviations-at-cooper-institute/
- Published: 2021-12-14T12:00:00.000Z
- Updated: 2026-09-14T17:25:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150765

A 7/8-7/19 FDA inspection at Cooper Institute for Advanced Reproductive Medicine, Houston, TX, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 12/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cooper-institute-619233-12152021?ref=fdaweb.com) says specific deviations were: 

- failing to test a specimen from an anonymous or directed donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents;
- failing to test a specimen from an anonymous or directed donor of cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract;
- failure of a responsible person to determine and document the eligibility of a donor of reproductive cells or tissue based on the results of donor screening and testing;
- failing to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases; and
- failing to establish and maintain procedures for all steps performed in testing, screening, and determining eligibility, and complying with all other donor eligibility requirements.

The letter says FDA has not received a response from Cooper on the inspection observations listed on the FDA-483 provided at the close of the inspection and thus the agency is unable to evaluate any corrective actions Cooper has implemented or planned.

Cooper was told to take prompt action to correct the violations and to respond with a list of steps it has taken or plans to take to correct the violations and prevent their recurrence, with documentation for each step and a timetable for completing the corrections.