FDA warns two Massachusetts infusion pump makers owned by same CEO

Regulatory NewsRegulatory News
| 15 August 2022 | By Ferdous Al-Faruque 

Two infusion pump manufacturers were handed similar warning letters for multiple issues, including failing to take adequate corrective actions after receiving product complaints, following up on those complaints and addressing product failures. The companies are owned by Chaoyoung Lee and headquartered at the same address in Massachusetts.
On 9 August the US Food and Drug Administration posted warning letters it had sent to infusion pump-makers Zyno Medical, dated 12 July, and InfuTronix, 16 June, that are owned by Lee and headquartered in Natick, MA. In both cases, the agency has been in contact with Lorraine Hanley, who is also VP for global quality and regulatory affairs at both companies.
According to the FDA, the companies failed to follow their own Corrective and Prevention Action (CAPA) plans and did not adequately explain why in their responses to the agency. They also noted that both companies trigger a CAPA request if they receive 10 product-related complaints within 12 months but did not provide an adequate rationale for that threshold.
“None of your promised actions have been completed and anticipated timeframes for the conduction and completion of your promised actions were not provided,” the letters state. “In your response, explain how the firm’s current criteria for receiving ten or more product-related complaints within a twelve-month period is an appropriate statistical methodology. Additionally, provide a timeframe for the activities promised as well as the results of activities as they become available.”
FDA inspectors also said Zyno Medical failed to adequately establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before implementing them. The agency lists a number of times and ways the company made design changes without properly going through the necessary procedures. While inspectors acknowledged receiving responses on how the design changes happened from the company, they say the rationales and actions taken so far are not sufficient.
Similarly, FDA says InfuTronix failed to “adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.”
The agency noted that the company’s procedure requires a complaint handling unit member to contact a complaint reporter when there is insufficient information on a complaint to try to obtain missing information.
“Your firm did not follow this process of attempting to obtain adequate information to perform review and evaluation of complaints received,” FDA said.
Finally, FDA inspectors said neither company adequately reviewed, evaluated and investigated complaints involving possible product failures based on their own processes and requirements, and provided examples. The agency noted in many of these cases the devices were supposed to have been returned for evaluation but there was no record they were.
“No further details regarding similar investigations, additional attempts to have the device returned, or further communication with the complainant are included in the complaint record,” FDA said.
In both cases, FDA has asked the company to respond in writing within 15 days on the steps it is taking to rectify the issues the agency has objected to.
“Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken,” the agency said. “If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.”
“If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed,” the agency added. “Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.”


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