FDA 483 - MedDev Manufacturing Sdn Bhd - May 04, 2023

An FDA inspection conducted from May 2 to May 4, 2023, at MedDev Manufacturing Sdn Bhd, a foreign medical device manufacturer located in Kiang, Selangor, Malaysia, identified two significant observations detailed in a Form FDA 483. The inspection highlighted deficiencies in the company's quality system, specifically concerning its record-keeping and document control practices. The primary issue involved inadequate procedures for device history records (DHRs). For instance, DHRs for CO2 detection devices lacked crucial traceability information regarding the assembly, testing, and release of specific batches. Furthermore, the company was found to be missing essential DHR procedures designed to ensure that devices are manufactured in strict accordance with their Device Master Records. The second observation noted that MedDev Manufacturing Sdn Bhd failed to adequately maintain its document control procedures, specifically referencing a critical procedure titled "Document & Data Control: QP 5.0 Revision: 01." These findings indicate non-compliance with the regulatory framework governing medical device manufacturing quality systems, as outlined by the Federal Food, Drug and Cosmetic Act. In response to the observations, MedDev Manufacturing Sdn Bhd committed to correcting both identified deficiencies.