FDA WARNING_LETTER - Centurion Medical Products Corporation - August 20, 2019

The FDA issued a Warning Letter to Centurion Medical Products Corporation following inspections in August and October-November 2019, identifying significant violations. The company manufactures sterile convenience kits, such as the Vascular Access Bundle, Perm Cath Removal Kit, and Ultimate Line Tray, which are classified as combination products (device and drug).

The primary violation is that these Convenience Kits are unapproved and uncleared for U.S. marketing, lacking required Premarket Approval (PMA) or 510(k) notification, rendering them adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. The FDA determined that the Center for Devices and Radiological Health (CDRH) would likely have lead responsibility for premarket review.

Furthermore, the inspections revealed manufacturing practices that compromise safety and effectiveness. Centurion opens original sterile packaging of components (e.g., hypodermic needles), repacks them in inadequately controlled environments, and then re-sterilizes the finished kit. This can introduce bioburden, increasing infection risk, and repeated sterilization may degrade components. Labeling issues were also noted, potentially leading to incorrect use.

The Convenience Kits are also adulterated due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), with the company's corrective actions