Fresenius Kabi Oncology, maker of generic intravenous oncology drugs, has received a warning letter from the Food and Drug Administration (FDA) citing manufacturing violations at the firm’s Kalyani facility in West Bengal. The letter says that an inspection of the facility last January found significant deviations from current good manufacturing practice for the manufacture of active pharmaceutical ingredients. Fresenius Kabi sent a response a month later, which the FDA says lacks sufficient corrective actions.
The agency claims Fresenius Kabi kept samples, data and results outside the local systems for assessing quality, which raised serious concerns regarding the integrity and reliability of the data generated at the plant. Federal investigators also said Fresenius Kabi “repeatedly delayed, denied, limited or refused to provide information” during the inspection.
The warning letter goes on to say that the company “failed to establish an effective corporate local system for managing quality, which would include the appropriate organizational structure, procedures, processes and resources, as well as activities to ensure confidence that all APIs produced by your facility will meet the intended specifications for quality and purity.”
The agency is recommending Fresenius Kabi hire a third party auditor as well as provide a corrective action that describes commitment, procedures, actions, and controls to ensure data integrity. If the company does not comply with the FDA’s orders, the agency has the authority to withhold approval of any new applications or supplements listing Fresenius Kabi, Kalyani as an API manufacturer.
Fresenius Kabi Oncology is a subsidiary of Fresenius Kabi AG, which is one of four business segments of Fresenius Medical Care, the world’s largest provider of dialysis services and products. The company currently faces hundreds of wrongful death lawsuits claiming the company’s dialysis products GranuFlo and NaturaLyte were improperly labeled and caused some patients to receive toxic levels of an ingredient that converts to bicarbonate in the body. Elevated levels of bicarbonate have been associated with serious heart complications including sudden cardiac arrest.
Source: Money Control