FDA 483 - SSN MEDICAL PRODUCTS SDN BHD - May 10, 2023

During an inspection conducted from May 8-10, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to SSN MEDICAL PRODUCTS SDN BHD, a foreign medical device manufacturer located in Seri Kembangan, Selangor, Malaysia. The inspection revealed significant deficiencies in the company's quality management system, falling under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Three primary observations were noted. First, the firm failed to adequately maintain document control procedures, specifically not adhering to their own quality documents and record control procedures. Second, there was a complete lack of established procedures for device history records (DHRs). This included an absence of general DHR procedures, a failure to ensure DHRs for latex examination gloves provided traceability of compounding and in-process testing, and the omission of primary identification labels from product DHRs. Finally, the procedures for receiving, reviewing, and evaluating customer complaints were found to be inadequately established. The complaint form used lacked critical information such as investigation details, device failure specifications, associated risks, device usage context, incident relationship, and complainant contact details. In response to these observations, SSN MEDICAL PRODUCTS SDN BHD committed to correcting all identified issues. The company is required to implement comprehensive corrective actions to address these quality system deficiencies.