Biologics

Multiple Violations in Akan Bio's Ayama

An FDA 9/20-9/30/2022 inspection at Akan Biosciences in Gaithersburg, MD, found the firm manufactures Ayama, an adipose-derived stromal vascular fraction cellular product for allogenic use that does not have agency approval. A just-released 4/30 Warning Letter says Ayama is regulated as both a drug and a biologic and must have a BLA in effect to be legally marketed.

The letter says the inspection also documented significant violations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) and evidence of significant violations of current good manufacturing practice regulations. Specific violations were:

failure to test a specimen from a donor of cells or tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents;
failure to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor or up to seven days before or after recovery;
failure to use appropriate FDA-licensed, approved, or cleared donor screening tests, according to the manufacturer’s instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases;
failure to screen a donor of 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;
failure to identify an HCT/P that is in quarantine pending completion of a donor-eligibility determination and failure to ship HCT/Ps with the required accompanying records for which the donor eligibility has not been completed;
failure to ship in quarantine a pre-distribution shipment of HCT/Ps between establishments for which the pre-established criteria designed to prevent communicable disease transmission have not been documented as being met;
failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failure to have an adequate system for monitoring environmental conditions in an aseptic processing area necessary to prevent contamination or mixups.

FDA says the firm’s responses to the inspection observations were inadequate. Akan was told to respond with a list of specific actions to address any violations and prevent their recurrence, with documentation of the actions and a schedule for completing them.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome