FDA 483 - JMS Healthcare PHL Inc. - May 12, 2023

An FDA inspection of JMS Healthcare PHL Inc., a manufacturer located in Tanauan City, Batangas, Philippines, was conducted from May 8 to May 12, 2023. The inspection resulted in two key observations indicating deficiencies in the firm's quality system. First, investigators noted that acceptance activities were not properly documented, specifically identifying that steps outlined in the bacterial endotoxin testing procedure were not recorded during product testing. Second, procedures for accepting incoming products were found to be inadequately established and followed. Review of multiple raw material lots released between January 2021 and May 2023 revealed that the company's standard operating procedure for sampling incoming materials, based on International Standard ISO 2859-1, was not consistently applied. These observations highlight a need for improved adherence to established quality control protocols, which are crucial for ensuring product safety and quality under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. JMS Healthcare PHL Inc. has indicated a commitment to correct both identified issues.