Cardinal Health Receives Warning Letter from US FDA Regarding Marketing of Unauthorized Devices

Vaccine bottle and syringe held by doctor with gloves.

As per the reports, the U.S. Food and Drug Administration (FDA) issued a warning letter to Cardinal Health (CAH.N) after an inspection at its Illinois facility. The agency identified the company’s involvement in marketing and distributing the unapproved medical devices sourced from a Chinese manufacturer.

Following the ongoing investigations into reports of quality issues, including leaks and breakages, associated with certain syringes manufactured in China, the FDA had previously advised against using select China-made syringes. This guidance was expanded last month.

Upon inspection, the FDA ascertained  Cardinal Health to import the two variants of syringes marketed under the Monoject Brand. The agency issued a letter on 24th April 2024, highlighting Cardinal’s marketing of kits featuring piston syringes produced by China’s Jiangsu Shenli Medical Production. Neither of these syringes possessed the requisite approvals for commercial distribution or investigational use.

These syringes serve critical functions in medical procedures, facilitating the injection or withdrawal of fluids from the body and delivering fluids or medications via feeding tubes to patients. In a separate advisory issued in November, the FDA cautioned healthcare providers and facilities against utilizing Cardinal’s Monoject syringes in conjunction with patient-controlled pain management pumps and syringe pumps, prompted by concerns over compatibility issues with the latter.

The FDA’s actions underscore its commitment to safeguarding public health and ensuring compliance with regulatory standards within the medical device industry.

Pharma Utility

Pharma Utility

Welcome to Pharma Utility, a magazine dedicated to news and services in the Indian pharmaceutical industry. Founded in the year 2007 by Mr. Digvijay Singh, in last 10 years we have moved leap and bound in making pharmacy knowledge available to all our partners.

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