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# InVia Fertility Specialists HCT/Ps Violations
- URL: https://www.fdaweb.com/invia-fertility-specialists-hct-ps-violations/
- Published: 2025-07-07T12:00:00.000Z
- Updated: 2026-09-14T15:15:35.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159447

A 1/28-2/5 FDA inspection at InVia Fertility Specialists in Hoffman Estates, IL, documents significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A just-released 6/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/invia-fertility-specialists-pllc-710632-06132025?ref=fdaweb.com) says the specific violations were:

- failure to test a specimen from an anonymous or directed reproductive donor of cells or tissues, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents;
- failure to screen a donor of reproducible cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases;
- failure to determine whether a donor is eligible based upon the results of donor screening;
- failure to prominently label an HCT/P from an ineligible directed reproductive donor with the Biohazard legend shown in regulations; and
- failure to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other regulatory requirements.

FDA says the firm’s responses to the inspectional observations did not include sufficient detail to be assessed for the adequacy of the response. The letter notes that a 9/2022 inspection resulted in two violations that were documented again in this inspection. “This indicates that your corrective actions were either not implemented or were not effective to prevent the recurrence of the previously identified violations,” it says.

InVia was told to promptly correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with any necessary documentation to show that correction has been achieved, and a schedule for completing the corrections.