FDA 483 - Mihalko Medical, LLC - February 17, 2017

An FDA inspection conducted at Hieber's Pharmacy, a producer of sterile drug products, from January 23 to February 17, 2017, identified significant deficiencies in their manufacturing processes and controls. The Form 483 issued to Joseph G. Bettinger, the owner, detailed multiple observations indicating non-compliance with quality standards for sterile drug production. Key violations included the absence of adequately defined or controlled areas for aseptic processing, leading to potential product contamination. For instance, the firm failed to properly qualify its ISO 5 glovebox isolator and surrounding room, lacked dynamic smoke studies, and had inappropriate cleaning practices such as dry sweeping and using non-sterile wipes. Personnel gowning procedures were also found to be inadequate, with technicians wearing non-sterile attire over street clothes in critical areas. Furthermore, Hieber's Pharmacy did not perform essential laboratory testing for sterility, pyrogen absence, or identity and strength for its sterile drug products, including Gentamicin. The company also lacked a written program for stability testing to support product beyond-use dates and to confirm antimicrobial effectiveness for preserved injectable products. Crucially, sterilization and depyrogenation processes for both finished drug products and components like vials and stoppers were not validated, raising significant concerns about product quality and patient safety. The firm is required to address these critical observations with comprehensive corrective actions to ensure compliance and prevent future contamination or quality issues.