# FDA 483 - California Cryobank LLC d.b.a. Cooper Surgical - June 07, 2024

Source: https://www.keypedia.com/records/483/california-cryobank-llc-dba-cooper-surgical/e5ff9d51-6929-451d-aaac-42426e95bd46

> FDA 483 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: 483
- Company Name: California Cryobank LLC d.b.a. Cooper Surgical
- Inspection Date: 2024-06-07
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of California Cryobank LLC d.b.a. Cooper Surgical in New York, NY, identified a significant issue with donor screening practices. The firm was found to be using an abbreviated donor screening procedure for repeat semen donors who had not completed a full screening within the preceding six months. This practice raises concerns regarding the thoroughness of donor eligibility determination for reproductive human tissue.

## 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)
- [EIR - 2024-06-07](https://www.keypedia.com/records/eir/california-cryobank-llc-dba-cooper-surgical/3752bd36-e93e-45ef-a565-2c89180d7288)

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961