FDA 483 - Partners In Care, Inc. - June 10, 2016

An FDA inspection of Partners in Care, Inc., a sterile drug producer in Gainesville, GA, took place from May 24 to June 10, 2016. The inspection identified six significant violations primarily related to sterile drug manufacturing and quality control. Key issues included the absence of a written testing program to support expiration or beyond-use dates for sterile products, with some dates exceeding component stability. Crucially, the firm lacked adequate validation for its sterilization and depyrogenation processes, did not use biological indicators, performed infrequent and unrepresentative media fills, and failed to conduct smoke studies to verify aseptic airflow. Additional observations cited a lack of documented procedures for managing multi-dose vial stopper punctures and for approving components, including the use of non-medical grade materials in sterile injectables. Environmental monitoring during active production was deficient, and equipment cleaning protocols lacked established hold times post-sterilization, with non-sterile wipes used in critical areas. These findings necessitate that Partners in Care, Inc. implement comprehensive corrective and preventive actions to ensure compliance with regulatory standards for sterile drug manufacturing and safeguard product quality, safety, and purity.