Biologic Manufacturer Did Not Test for Diseases, Gets FDA Warning Letter

Akan Biosciences, the manufacturer of a sterile injectable biologic product, received an FDA Warning Letter for failing to properly test donor tissue samples for communicable diseases and failing to have an approved BLA.

The Warning Letter follows an FDA inspection Sept. 20-30, 2022, where investigators found that the product — Ayama — is an “an injectable product intended to ‘repair, reconstruct and replace your skin tissue.’” However, donors provide adipose tissue, and the company’s “product is not intended to perform the same basic function or functions of adipose tissue in the recipient as in the donor,” the letter says, adding that “Using your product for the repair, reconstruction, and replacement of skin tissue, for example, is not homologous use” and requires a BLA.

The company responded to the 483 inspection observations, the letter says, and recalled the product, but the FDA “determined that the response is inadequate” regarding the disposition of any remaining product on hand and plans to provide “significant documentation to assure that the product has the identity, strength, purity, and quality” for the product.

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