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# HCT/Ps Issues at California IVF Fertility Center
- URL: https://www.fdaweb.com/hct-ps-issues-at-california-ivf-fertility-center/
- Published: 2020-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:08:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146415

A 10/4-10/11/19 FDA inspection at California IVF Fertility Center, Sacramento, CA, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A just-released 2/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/california-ivf-fertility-center-598552-02262020?ref=fdaweb.com) says the specific deviations were: 

- failing to test a specimen from an anonymous or directed donor of reproductive cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents;
- 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 agents and diseases; and
- failing to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility, and complying with all other requirements of a specified regulation.

The letter says the clinic objected to the inspection observations on the basis that FDA guidance documents contain recommendations unless specific regulatory or statutory requirements are cited. It then cites the basis in regulations for the three observations. FDA acknowledged the clinic’s commitment to revise its procedures and donor screening forms to ensure they include an evaluation of all risk factors for, and clinical evidence of, relevant communicable diseases, as required under regulations. The agency says it will review the documents during the next inspection.

California IVF was told to take prompt action to correct the violations addressed in the letter and prevent their recurrence and to respond with a list of specific steps taken or planned and a timetable for completion of the steps.