Biologics

Cell Product Deviations at Virginia Center

David McFarland

— 2 min read
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A 2/13-2/25 FDA inspection at the Virginia Center for Reproductive Medicine, Reston, VA, identified significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 7/1 Warning Letter says specific deviations were: 

  •          failing to test a specimen from an anonymous or directed reproductive donor of cells and 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 disease agents and diseases;
  •          failing to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required;
  •          failure of a responsible person to determine and document the eligibility of a donor of reproductive cells or tissue based on the results of donor screening and testing;
  •          failing to determine whether a donor is eligible based on the results of donor screening and donor testing; and
  •          failing to provide a summary of records to accompany a human cell, tissue, or cellular and tissue-based product that contains a listing and interpretation of the results of all communicable disease tests performed.

The letter says the firm’s response to the inspection observations was inadequate to address the agency’s concerns. It also notes that a 2013 inspection resulted in a 9/10/13 Warning Letter. “Despite your commitment to correct the previously noted violations,” FDA says, “the current inspection documented many of the same violations, indicating that your corrective actions were either not implemented or were not effective to prevent the recurrence of the previously identified violations.”

FDA also takes the rare step of specifically addressing in detail each of the firm’s responses and proposed corrective actions to raise its concerns.

“We continue to be concerned about your ability to implement effective corrective actions,” the agency says. The center was told to respond with a list of specific actions to correct the violations and prevent their recurrence, with a schedule for completion. The company also was told to schedule a meeting with FDA to discuss its lack of compliance with the regulations.

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