Human cells and tissues must be vigorously tested for contamination from infectious pathogens. Seems like a common sense approach to easily avoid spread of infectious diseases. But not every collection, processing, and storage site for human tissue follows this simple screening step for their operations. A Sperm Bank in California got a Warning Letter for inadequate testing of the biospecimen their collected.
The 21 CFR 1271 regulation lays out explicit requirements for infectious disease testing and donor screening. These include review of medical records, donor questionnaire, and blood tests for common blood- and tissue-borne infectious agents (mostly viruses and parasites). The tests must be completed prior to collection or immediately after sample collection. If tests are done after collection, the biospecimen must be strictly quarantined to avoid accidental release. The infectious disease tests must be conducted using FDA-certified donor testing methods.
These rules have existed for over 20 years and have worked well to allow safe human cellular and tissue-based products (HCT/Ps). So, it is surprising when a organization such as the Fertility Center of California is found non-compliant. The facility claims to be in business for almost 45 years. The FDA auditors found several easily preventable but high-risk activities at the facility.
The FDA Warning Letters only give one side of the picture as we don’t know what was the facility’s risk-assessment and risk-mitigation process for their operations, and how they responded to the FDA audit, but we can assume that there are no reports of infections and other adverse events in the recipients of the material stored at the facility, not that it excuses the non-compliant behaviour. It’s a note of caution to all such facilities operating in the US.
