FDA Warns 2 Firms on Human Cells/Tissues

FDA has issued Warning Letters to two medical firms for violations involving human cells, tissues, and cellular and tissue-based products (HCT/Ps). A 6/27 Warning Letter went to New Hope Center for Reproductive Medicine in Virginia Beach, VA, following a 12/8/22-1/23/23 agency inspection there. The letter says specific violations were:

• 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 diseases agents and diseases;
• failing to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor; or for oocyte donors up to 30 days before recovery or up to seven days after recovery; and
• failing to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility, and complying with all other regulatory requirements.

The letter says New Hope’s 2/3 response to the form FDA-483 provided at the end of the inspection was inadequate to address the agency’s concerns. “We recommend that you review your firm’s procedures and make the necessary changes to ensure they include all steps you perform in testing, screening, determining donor eligibility, and complying with all other requirements,” FDA says.

New Hope was told to respond with a list of specific steps it has taken or plans to take to correct the noted violations and prevent them from occurring in the future, with any related documentation and a schedule for completing the corrections.

A 3/21-3/30/22 inspection at Row1, doing business as Regenerative Labs in Pensacola, FL, documented that the company manufactures several cellular products derived from human umbilical cords. A 6/21 Warning Letter says the products have been distributed to doctors and medical clinics throughout the U.S.

The letter says the products are considered legally to be drugs and biologics and also are HCT/Ps that are regulated as drugs or biologics. FDA says the firm does not have an approved BLA or IND for its products and thus is illegally marketing them. Current good manufacturing practice violations that were observed during the inspection were:

• failing to establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes;
• failing to establish written procedures for production and process control to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
• failing to establish and follow a written testing program to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates.

FDA says the firm’s 4/20/22 and 8/22/22 responses to the form FDA-483 inspection observations were inadequate. Regenerative Labs was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation to show the matters have been addressed and a schedule for completing the corrections.