Biologics

RenatiLabs Illegally Marketing WJMAX

David McFarland

— 1 min read
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An 8/2-8/12/22 FDA inspection at RenatiLabs in Erlanger, KY, determined that the firm manufactures WJMAX, a product derived from human umbilical cord, for allogeneic use. A just-released 6/1 Warning Letter says the product is distributed directly to doctors throughout the U.S. to administer by intra-articular injection or topically to open wounds. It purports to be sterile, the letter says.

Such products are human cell, tissue, or cellular or tissue-based products (HCT/Ps), FDA says, and require an approved BLA or IND to be lawfully marketed, neither of which RenatiLabs has.

The letter also lists these significant deviations from current good manufacturing practice (CGMP) regulations:

  • failing to reject drug products failing to meet established standards or specifications and any other relevant quality control criteria;
  • failing to establish and follow appropriate written procedures designed 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 designed to assure drug products have the identity, strength, quality, and purity they purport or are represented to possess;
  • failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
  • failing to prepare batch production and control records for each batch of drug product produced that include documentation that each significant step in the manufacturing, processing, packing, or holding of the batch was accomplished; and
  • failing to establish and follow a written testing program designed to assure the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates.

RenatiLabs was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation showing that the matters have been addressed, and a schedule for completing the corrections.

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