FDA 483 - Sancilio & Company, Inc. - January 20, 2017

During an inspection conducted from January 9 to January 20, 2017, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Sancilio & Company, Inc., a prescription drug manufacturer located in Riviera Beach, FL. The observations highlighted significant deviations from Current Good Manufacturing Practices (cGMP). Key deficiencies included a substandard laboratory control system, with analytical test methods lacking scientific soundness and adequate validation to assure drug product quality, strength, and purity. The firm's stability program was found to be unreliable, marked by unjustified method changes and testing delays. Critical laboratory records were incomplete, failing to include all test data, particularly initial failed results, and data backup practices were insufficient, jeopardizing data integrity. The Quality Control Unit exhibited a systemic failure to thoroughly investigate product stability failures and unexplained discrepancies, leading to open corrective action plans without timely resolution. Additionally, equipment was not always of appropriate design, and cleaning and maintenance procedures were not consistently followed. To address these serious concerns, Sancilio & Company is required to submit a comprehensive response detailing corrective and preventive actions to rectify these issues and ensure full compliance with regulatory standards for drug manufacturing.