Drugs

5 CGMP Observations in CARsgen Inspection

An 11/28-12/6/2023 FDA inspection at the CARsgen Therapeutics Corp. facility in Durham, NC, found significant violations of current good manufacturing practice (CGMP) regulations in the manufacturing of investigational new drugs and biological products that were made available for use in a Phase 2 trial. A just-released 7/28 Warning Letter says the specific violations were:

failure to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin, and failure to hold and dispose of trash and organic waste matter in a timely and sanitary manner;
failure to establish an adequate system for preventing contamination and monitoring environmental conditions in aseptic processing areas, and failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
failure to establish written procedures for production and process control to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

“The nature of your above-listed violations demonstrates that you have failed to ensure that your firm manufactures products that meet established specifications for identity, strength, quality, and purity,” FDA says. It acknowledges that the company has paused manufacturing its products as of 12/12/2023, notified clinics to administer previously released drug products to patients, and has plans for the disposition of products remaining in its control.

FDA told CARsgen to respond with a list of specific actions it has taken or plans to take to address violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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

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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