The U.S. FDA has issued warning letters to Zyno Medical and InfuTronix for failing to investigate potential product failures that were linked to company device complaints.
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.
Read the full article on Regulatory Focus.