FDA warns four device makers over lax processes

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently warned four medical device makers about a range of failures in procedures and processes. Two letters were sent to eye product manufacturers in the US, a third to a US developer of hemostatic products, and the fourth was related to a German company’s blood collection system.

New 510(k) needed for SAFE-T-FILL blood tubes

Kabe Labortechnik of North Rhine-Westphalia, Germany received a warning letter on May 9, following an inspection from 6-9 January.

The company manufactures SAFE-T-FILL capillary blood collection systems. According to the letter, the company violated quality system regulations, with processes not up to current good manufacturing practice (GMP) standards. For example, it did not validate the manufacturing process for the SAFE-T-FILL systems, which are filled onsite with an anticoagulant coated in a capillary rod, a “critical component” in the device, the agency noted.

Software used to inspect the coated capillary rods “was installed many years ago and has not been validated,” according to the letter.

Given that the machines and software are not validated, it’s unclear how the products meet quality specifications, FDA concluded. The agency asked the company to provide a systemic corrective action plan for all devices manufactured and sold in the US.

“Design changes, including the impact of cumulative changes should be assessed to determine if a new 510(k) is needed,” FDA advised.

FDA also flagged failure to develop, maintain and implement medical device reporting (MDR) procedures, such as a plan for reporting adverse events promptly to FDA.

The agency wrote that it is taking steps to refuse entry of these devices into the United States – detention without physical examination – until these violations are addressed and gave the company 15 working days to respond to the letter.

NeuroSync warned over VR headset design controls

NeuroSync, of Holliston, Massachusetts, received a warning letter about cGMP violations from on May 9, following a 6 January-5 February inspection of the company’s facility where it manufactures EYE-SYNC, a virtual reality headset and computer tablet used for assessing eye movements.

According to the warning letter, inspectors concluded the company had failed to establish and maintain procedures to control the design of the device and ensure that specified requirements are met, such as accuracy of eye tracking performance test results. Also, per software specs, if data quality is insufficient, users should be alerted and results should not be relayed, but the company did not test the product to ensure the product was working properly in this regard.

FDA also flagged violations related to failing to report corrections and removals following product failures.

“CDRH’s risk assessment concluded the devices failing to perform as intended may cause temporary or medically reversible adverse health consequences or a remote probability of serious adverse health consequences,” FDA wrote in the letter.

FDA urged NeuroSync to address violations promptly or else face regulatory actions, including seizure, injunction, and civil money penalties. The company had 15 working days to respond.

Microspecialties warned for sterilization shortfall

Microspecialties was sent a warning letter about cGMP violations on 8 May, following an inspection 14 January-18 February at the company’s site in Middletown, Connecticut.

The company contract manufactures Class I/II ophthalmic surgical devices, including sterile I-PACK injection kits, punctum plugs, and microkeratome blades.

According to the letter, the company failed to fully implement parts of its sterilization process control procedures. In March 2024, the company released lots of intravitreal injections without sending them to be sterilized, resulting in a Class II recall by Microspecialties and a Class I recall by the customer, according to the letter.

The letter also noted failure to implement parts of the companies process validation procedures, among other violations. The firm needs to promptly address FDA’s concerns or else face regulatory actions and penalties without further notice. It was given 15 working days to respond to the letter.

United Health Products flouts clinical trials rules

United Health Products, of Mt. Laurel, New Jersey, received a letter 24 March, following an inspection 23 September-4 October 2024 by the agency’s Office of Bioresearch Monitoring Inspectorate (OBMI).

According to the letter, the company failed to submit an investigational device exemption (IDE) application and obtain approval before a study testing investigational hemostatic products. The products are used during surgical procedures and FDA determined they are Class III, significant-risk devices, which require notification.

FDA also charges that the company failed to ensure proper monitoring of the trial, for example there was no effective clinical monitoring plan.

“Inadequate monitoring can lead to reporting of inaccurate data, missing data, enrollment of subjects that do not meet eligibility criteria, and poot adverse event reporting, among other concerns,” FDA wrote. “In addition, without adequate monitoring there is no assurance that your study conduct is compliant and that any instances of noncompliance are resolved properly.”

According to FDA, the company failed to evaluate unanticipated adverse device effects and report results of the evaluation to FDA, reviewing institutional review boards and participant investigators.

The company was given 15 working days to respond in writing to the letter.

Kabe Labortechnik, NeuroSync, Microspecialties, United Health Products

FDA warns four device makers over lax processes

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