Drugs

Kimera Labs Illegally Marketing Exosomes: FDA

David McFarland

— 2 min read
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A 7/11-7/22/2022 FDA inspection at Kimera Labs in Miramar, FL, determined that the company manufactures and distributes two exosome products and an amniotic fluid product for allogeneic use. A 9/1 Warning Letter says the products have been distributed to practitioners and medical facilities throughout the U.S. The letter says the products purport to be sterile and the amniotic fluid product is intended to be injected.

FDA says the products are legally considered to be drugs and biological products because they are intended to treat various diseases and conditions. Thus, they cannot be marketed without an approved IND or BLA in place, which the company does not have.

The letter also says the agency investigators documented evidence of significant deviations from current good manufacturing practice (CGMP) requirements. It says that specific deviations, involving over 37,000 vials manufactured between 4/2020 and 7/2022 were:

  • failing to establish appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for all aseptic and sterilization processes;
  • failing to always make written records of investigations into unexplained discrepancies or the failure of a batch or any of its components to meet specifications, whether or not the batch has already been distributed;
  • failing to have each batch of drug product purporting to be sterile and/or pyrogen-free laboratory tested to determine conformance to such requirements;
  • 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 establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
  • failing to test non-penicillin drug products for the presence of penicillin although a reasonable possibility exists that the non-penicillin drug products have been exposed to cross-contamination with penicillin;
  • failing to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
  • failing to establish and document the accuracy, sensitivity, and reproducibility of test methods;
  • failing to ensure that each lot of components, drug product containers, and closures are withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit; and
  • failing to establish and follow a written testing program designed 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.

The agency acknowledges receipt of correspondence from Kimera and says its responses are not adequate to address the violations. FDA also says Kimera is continuing to manufacture and distribute products to treat diseases or conditions in humans without an approved BLA or IND, despite being issued a 4/2020 Untitled Letter on that issue.

Kimera was told to respond with a list of specific steps it has taken or plans to take to address any violations and prevent their recurrence, with documentation necessary to show that matters have been addressed, and a schedule for completing the corrections.

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