# FDA EIR - California Cryobank LLC d.b.a. Cooper Surgical - June 07, 2024

Source: https://www.keypedia.com/records/eir/california-cryobank-llc-dba-cooper-surgical/3752bd36-e93e-45ef-a565-2c89180d7288

> FDA EIR for California Cryobank LLC d.b.a. Cooper Surgical on June 07, 2024. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: California Cryobank LLC d.b.a. Cooper Surgical
- Inspection Date: 2024-06-07
- Product Type: Biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: California Cryobank LLC, operating as Cooper Surgical, underwent an unannounced FDA surveillance inspection from May 31 to June 7, 2024. Conducted under CP 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/Ps), the inspection revealed significant compliance issues. The main violation, detailed in an FDA Form 483, was the firm's use of an abbreviated screening procedure for repeat anonymous semen donors. Specifically, recurring medical social questionnaires did not thoroughly re-screen donors for risk factors across the complete timeframe, violating 21 CFR 1271.75(e). Additional concerns raised by the FDA included the absence of screening for variant Creutzfeldt-Jacob Disease (vCJD) and a failure to inquire about positive West Nile Virus (WNV) tests within the preceding 120 days. Instances of undocumented donor travel to Zika virus risk areas were also identified. The FDA advised the company to improve tracking of donor physical examinations to prevent the destruction of non-compliant tissues and to monitor WNV testing timeframes diligently. The Laboratory Manager committed to providing a written response to the FDA 483 observation within 15 business days, with the FDA reiterating that failure to address these issues could result in legal sanctions.

## Related Documents

- [EIR - 2010-01-13](https://www.keypedia.com/records/eir/california-cryobank-llc-dba-cooper-surgical/77e36982-4c93-49a3-870c-a7c0be0c069c)
- [EIR - 2019-07-09](https://www.keypedia.com/records/eir/california-cryobank-llc-dba-cooper-surgical/a7494ca4-94bd-4f3f-9efe-c12423389814)
- [EIR - 2022-07-25](https://www.keypedia.com/records/eir/california-cryobank-llc-dba-cooper-surgical/6ad540c3-03a9-4c89-bd8f-0e1e7da5d430)
- [483 - 2024-06-07](https://www.keypedia.com/records/483/california-cryobank-llc-dba-cooper-surgical/e5ff9d51-6929-451d-aaac-42426e95bd46)

## Related Officers

- [recipient](https://www.keypedia.com/people/rebecca-w-lehde/1cbcdcb2-f5d3-4a19-afba-989bcd0a6e96)
- [company_representative](https://www.keypedia.com/people/beatrice-fetch/2b83e0fc-5599-4ad2-8a92-35a68389e7cc)
- [company_representative](https://www.keypedia.com/people/kareema-thompson/452c68ad-e4d4-4206-a95b-a4853652978c)
- [Branch Supervisor](https://www.keypedia.com/people/katherine-dominguez/816e8667-28d9-4543-88a2-5d2714d5fe4f)
- [company_representative](https://www.keypedia.com/people/betsy-wilson/9a6155fd-5c6b-4409-9447-83771bb97623)

Company: https://www.keypedia.com/companies/california-cryobank-llc-dba-cooper-surgical/89e90c23-7087-461e-9e34-f81d535f450e

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1