KBMED Successfully Completes FDA Inspection with High Marks

KL KBMED
Jul 14
2 min read

July 2025, We are proud to announce that KB Medical Group (www.kbmed.com) has completed a rigorous on-site audit conducted by the U.S. FDA’s Office of Import Division 1 (OII). Over three intensive days, the FDA inspection team carried out a comprehensive, high-standard audit that covered every aspect of our operations—from quality manuals, procedural documents, and record forms to design control processes and implementation.🏆

The inspectors conducted a thorough review of our employee training protocols and role responsibilities, leaving no aspect of our operations unchecked. Their comprehensive, all-angle approach ensured that every component of our quality system was evaluated with precision and rigor.

“This result reflects the discipline and excellence we strive for across all levels of the company,” said Susan S., CEO of KBMED. “Passing such a rigorous FDA audit with a near-perfect report reinforces our commitment to delivering safe, high-quality medical devices to the global market.”

“From documentation to design controls, every department showed alignment with FDA standards,” added Ruffy L., Manager of KBMED. “This milestone demonstrates the strength of our internal systems and the dedication of our people.”

About FDA Inspections: Process and Requirements

The U.S. Food and Drug Administration (FDA), through its Office of Import Division (OII) under the Office of Regulatory Affairs (ORA), conducts thorough inspections of overseas manufacturers to ensure compliance with U.S. medical device regulations, especially the Quality System Regulation (QSR) outlined in 21 CFR Part 820.

These inspections may be routine, for cause, or unannounced. They typically assess the manufacturer’s entire quality management system, including documentation, production processes, employee training, and compliance with design and risk controls.

FDA inspectors review: