Device makers warned for unauthorized modifications, cGMP violations

The US Food and Drug Administration (FDA) has cited ICU Medical for making changes to its infusion pumps without getting new marketing authorization and Noah Medical Corporation for failing to follow its corrective action and preventive action (CAPA) protocols.

FDA recently published two warning letters, including a 4 April notice to ICU Medical for making changes to its Medfusion Model 400 Syringe Infusion Pumps and CADD Solis VIP Ambulatory Infusion Pumps without first obtaining proper marketing authorization. The company acquired the pumps from Smiths Medical in $2.35 billion deal in 2022.

ICU Medical

FDA investigators inspected the company's Minneapolis, MN, facilities last summer and discovered that it had made significant changes to its infusion pumps and marketed them without seeking proper clearance.

“Such modifications can significantly impact the functionality of the device with respect to the infusion pumps delivery profile, alarm functionality, etc., and affect the device’s risk profile for risks related to under- or over-infusion, delay in therapy, incomplete therapy, or false alarms leading to adverse health effects for patients such as overdose, volume overload, or cardiorespiratory compromise,” said FDA. “Your documentation collected during the recent inspection describing the 510(k) risk-benefit analysis for the Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump indicates that these changes were implemented after the most recent clearances of the devices as noted above.”

The investigators also said that ICU Medical issued a class I recall of its infusion pumps, which included a software update. They noted that the company failed to submit a 510(k) in conjunction with the change and said that including a label change that states the device software has not undergone FDA review is insufficient.

“The changes that you made to the risk control measures in an effort to mitigate the hazards that were the basis for a Class I recall were not submitted to FDA in a required 510(k) even though your own procedure indicates that submission of a 510(k) would be required in this situation,” said FDA. “However, you only documented to the file that you had made the change and did not submit the required 510(k).”

The agency said ICU Medical should address the violations promptly, and failing to do so could result in seizure, injunction, and fines.

Noah Medical

FDA also sent Noah Medical a warning letter earlier this month, citing it for several current good manufacturing practices (cGMP) violations associated with its Galaxy System bronchoscopes and accessories. In particular, the company was cited for failing to follow its own CAPA procedures, and the agency noted that in two of the 17 CAPA records it reviewed, it failed to identify root causes and take the necessary CAPA steps.

FDA said Noah Medical failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and procedures for design control. The agency also cited the company for failing to establish and maintain procedures to control products that do not meet its requirements.

“Specifically, your procedure, ‘Nonconforming Material,’ (SOP-018 Rev. G, Effective Date: 09/24/2024,), has not been adequately implemented,” said FDA. “Your firm failed to conduct investigations to identify the root cause(s) as required by your nonconforming material procedure.”

Investigators said Noah Medical failed to establish and maintain procedures to rework products that do not conform to specifications by properly retesting and reevaluating them. For example, the agency said the company did not include procedures to determine if there were any adverse effects associated with reworking a device.

Finally, FDA said Noah Medical failed or refused to provide materials and information as part of the agency’s review of potential adverse events. In some cases, the company did not file a medical device report (MDR) after an adverse event, and in other instances, it filed an MDR after the 30-day filing requirement. The company responded to the citations, including its failure to file MDR reports, but the agency said the responses were inadequate.

“The responses indicate that your firm initiated a root cause investigation, plans to streamline its MDR reporting process, and is conducting a retrospective review of complaints for reportability,” said FDA. “However, in the responses, your firm did not include documentation or evidence to demonstrate that the systemic corrective actions have been fully implemented, as these efforts are still ongoing.”

“Our inspection also revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17,” the agency added.

FDA has given both companies 15 days to respond to the warning letters.

ICU Medical, Noah Medical Corporation

Device makers warned for unauthorized modifications, cGMP violations

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