FDA 483 - The Folger Coffee Company - March 12, 2025

During an inspection conducted from September 5-15, 2023, at PharmaTech Inc.'s manufacturing facility, the FDA investigator observed several deficiencies in adherence to Current Good Manufacturing Practices (cGMP). Key observations documented in the FDA Form 483 included a lack of adequate written procedures for equipment calibration and maintenance, leading to potential inconsistencies in process control. Furthermore, investigations into out-of-specification results were found to be insufficient, failing to thoroughly identify root causes and implement effective corrective and preventive actions. The inspection also highlighted issues with environmental monitoring systems, specifically regarding the aseptic processing areas, where data integrity and documentation practices were noted as suboptimal. Additionally, personnel training records lacked complete documentation of training effectiveness for critical manufacturing steps. These observations indicate a need for significant improvements in the company's quality management system to ensure product quality and patient safety. PharmaTech Inc. is required to provide a comprehensive response detailing its proposed corrective actions, timelines for implementation, and a plan for preventing recurrence of these violations to ensure full compliance with regulatory standards.