FDA 483 - JHK, Inc. - September 11, 2025

An FDA inspection conducted from September 9-11, 2025, at JHK, Inc. (dba American Safety & First Aid), a drug repackager and relabeler located in Osceola, IN, resulted in a Form FDA 483 listing ten significant observations. These observations highlight a critical lack of compliance with current Good Manufacturing Practices (CGMP) regulations. The main issues centered on a fundamental absence of written procedures and controls across various operational and quality systems. Key deficiencies included the absence of written procedures for the Quality Control Unit's core responsibilities, such as managing deviations, corrective and preventive actions, and change control. The firm also lacked procedures for annual product evaluations, facility sanitation, and proper warehousing practices, leading to observations of unsanitary conditions and inadequate product storage controls. Further violations involved insufficient control over labeling and packaging materials, including a lack of procedures for their receipt, examination, and issuance. The firm did not conduct pre-use inspections of packaging areas, had uncontrolled label printing access, and no label reconciliation. Employee training on CGMP requirements was undocumented and insufficient. Critically, there was no system for product distribution traceability to facilitate recalls, nor were reserve samples retained as required. To address these observations, JHK, Inc. is required to develop and implement comprehensive written procedures, establish robust quality control systems, ensure adequate facility maintenance and environmental controls, tighten labeling and packaging material management, provide documented CGMP training, and create effective product traceability and sample retention programs to ensure compliance with regulatory standards.