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Wednesday, March 25, 2009
Cardinal Health 303, Inc. Not in Compliance with Current Good Manufacturing Practices
In 2007, Cardinal Health 303, Inc., a California infusion pump manufacturer, signed a Food and Drug Administration decree to cease manufacturing one line of defective medical devices–specifically, one if its infusion pump lines–until it came into compliance with current Good Manufacturing Practices (cGMP) and Quality System (QS) regulations. Infusion pumps are medical devices used to deliver intravenous medications and fluids to patients.
The company was in the process of making corrections when QS deviations in another line of their infusion pumps were found. These deviations included, among others, a failure to notify the FDA, timely, of a malfunction that could cause or contribute to a death or serious injury if it recurred, and failure to develop a system to investigate complaints of malfunctions or failures. The FDA then sought amendments to the original decree to include all of the company’s infusion pump lines.
In a February 2009 news release Cardinal Health signed an amended decree to correct the violations of cGMP in the production of all of their infusion pumps. The amended decree adds requirements for the company to submit a corrective action plan for bringing all pumps being used in the United States into compliance with the Federal Food Drug and Cosmetic Act. They are also to retain an independent expert consultant who will inspect all of their infusion pump facilities and their recall procedures. The consultant will certify to the FDA that all required corrections have been made.
Once this level of compliance has been reached, Cardinal Health 303 is to hire an independent auditor to make annual inspections of all of its infusion pump facilities and report to the FDA its findings for four years. If future violations are found, the FDA is authorized to order Cardinal Health to cease manufacturing and distributing it products, and to recall all products, impose stiff fines and take other actions.
Additional Reporting Requirements
The 1990 Safe Medical Devices Act (SMDA) required device-using facilities to report malfunctioning equipment and failures that could cause or contribute to a death or serious injury if it recurred, to either the manufacturer or the FDA (or both) per circumstances specified in the SMDA. The SMDA also imposes a duty on the facility using the equipment (e.g., hospitals) to isolate and report defective equipment within a specified period of time.
This means that manufacturers will be notified by any facility that experiences a malfunction, and they, in turn are required to report the malfunction to the FDA. Under certain circumstances, the user is to report to the FDA in addition to the manufacturer. The manufacturer has no reason not to be aware of malfunctions or failures of their equipment.
The SMDA also holds the individual operator (e.g., nurses, doctors) personally responsible to report faulty equipment to a designated person within the facility, and imposes penalties of fines and imprisonment for failure of either the individual operator who discovered the malfunction or the facility’s designated contact to report the event.
If you have suffered from an injury or death of a loved one as a result of product defects, The Cochran Firm is prepared to do a full investigation to defend your product liability claim. Please contact the experienced product liability attorneys at The Cochran Firm in Dallas, Texas for a consultation and case review.
The company was in the process of making corrections when QS deviations in another line of their infusion pumps were found. These deviations included, among others, a failure to notify the FDA, timely, of a malfunction that could cause or contribute to a death or serious injury if it recurred, and failure to develop a system to investigate complaints of malfunctions or failures. The FDA then sought amendments to the original decree to include all of the company’s infusion pump lines.
In a February 2009 news release Cardinal Health signed an amended decree to correct the violations of cGMP in the production of all of their infusion pumps. The amended decree adds requirements for the company to submit a corrective action plan for bringing all pumps being used in the United States into compliance with the Federal Food Drug and Cosmetic Act. They are also to retain an independent expert consultant who will inspect all of their infusion pump facilities and their recall procedures. The consultant will certify to the FDA that all required corrections have been made.
Once this level of compliance has been reached, Cardinal Health 303 is to hire an independent auditor to make annual inspections of all of its infusion pump facilities and report to the FDA its findings for four years. If future violations are found, the FDA is authorized to order Cardinal Health to cease manufacturing and distributing it products, and to recall all products, impose stiff fines and take other actions.
Additional Reporting Requirements
The 1990 Safe Medical Devices Act (SMDA) required device-using facilities to report malfunctioning equipment and failures that could cause or contribute to a death or serious injury if it recurred, to either the manufacturer or the FDA (or both) per circumstances specified in the SMDA. The SMDA also imposes a duty on the facility using the equipment (e.g., hospitals) to isolate and report defective equipment within a specified period of time.
This means that manufacturers will be notified by any facility that experiences a malfunction, and they, in turn are required to report the malfunction to the FDA. Under certain circumstances, the user is to report to the FDA in addition to the manufacturer. The manufacturer has no reason not to be aware of malfunctions or failures of their equipment.
The SMDA also holds the individual operator (e.g., nurses, doctors) personally responsible to report faulty equipment to a designated person within the facility, and imposes penalties of fines and imprisonment for failure of either the individual operator who discovered the malfunction or the facility’s designated contact to report the event.
If you have suffered from an injury or death of a loved one as a result of product defects, The Cochran Firm is prepared to do a full investigation to defend your product liability claim. Please contact the experienced product liability attorneys at The Cochran Firm in Dallas, Texas for a consultation and case review.
Labels: Dallas
posted by Benjamin A. Irwin at 11:45 AM
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