FDA WARNING_LETTER - Bioptimal International - November 11, 2023

On April 3, 2024, the FDA issued a Warning Letter to Ms. Chunhong following an inspection from November 6-11, 2023, in Singapore, Southwest. The inspection found that the firm manufactures Thermodilution Catheters and Pulmonary Artery Monitoring Catheters, which are considered devices under the Federal Food, Drug, and Cosmetic Act.

The firm was cited for "Unapproved Device Violations" because it made significant changes to the cleared Thermodilution Catheter (K101669), including removing the polyvinylchloride (PVC) tubing heparin coating, without submitting a new 510(k) premarket notification. This change could increase friction and negatively impact thrombogenicity, potentially leading to blood clotting and embolization. Additionally, the firm is marketing a Pulmonary Artery Catheter, claiming it has the same design as the cleared Thermodilution Catheter, but it has different technological characteristics (e.g., 2- and 3-lumen configuration, no thermistor), requiring a new 510(k). Both devices are deemed adulterated and misbranded due to lack of proper clearance or notification.

"Quality System Violations" were also identified, indicating non-conformity with current good manufacturing practice requirements (21 CFR Part 820). Specific violations include: 1. Failure to adequately maintain complaint files and establish procedures for receiving, reviewing, and