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

During an inspection conducted from November 13 to November 16, 2023, the FDA issued a Form 483 to Cooper Institute for Advanced Reproductive Medicine in Houston, TX. The inspection revealed significant concerns regarding the facility's compliance with regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps).

The main violations centered on inadequate donor eligibility determinations and record-keeping practices. Issues included failing to test donors for all relevant communicable diseases, such as West Nile Virus, and prematurely deeming donors eligible before all required testing results were received. The facility also failed to properly label HCT/Ps from incompletely screened donors and utilized an insufficient donor screening questionnaire that omitted crucial risk factors like CJD and recent smallpox vaccination.

Repeated observations highlighted a lack of established, detailed procedures for donor screening, testing, physical exams, and eligibility determinations. Furthermore, record summaries lacked essential information like the establishment's address for eligibility determination and confirmation of CLIA-certified laboratory testing. Donor anonymity was compromised by including personal information in records shared with intended parents, and HCT/Ps were not consistently quarantined pending full eligibility. The use of non-indelible records and the absence of a procedure for handling CMV-reactive donors were also noted.

To achieve compliance with FDA regulations, Cooper Institute must implement comprehensive corrective actions, including revising screening protocols, ensuring complete testing prior to eligibility, establishing robust standard operating procedures, improving record integrity, and safeguarding donor anonymity to prevent the transmission of communicable diseases.