FDA 483 - Omega Laboratories Ltd. - January 17, 2024

An FDA inspection was conducted at Omega Laboratories Ltd. from January 9 to January 17, 2024, identifying critical deficiencies in their sterile drug manufacturing operations. The findings, documented in a Form FDA 483, point to two main issues requiring attention to comply with Current Good Manufacturing Practices. The first observation concerns the design and setup of the RABS vial filling machine (PP1-PPK01-FIL01). Inspectors noted that this equipment, used for aseptic filling of sterile drug products such as various injections, did not consistently ensure that sterile components like syringes and stoppers were handled under unobstructed first-pass HEPA filtered air. Personnel were observed impeding this critical airflow during setup, compromising aseptic conditions. The second major observation highlighted inadequate sanitation practices. Surfaces within the RABS of the vial filling machine, which were contacted by production operators during critical setup and interventions, were not disinfected before filling operations commenced or resumed. This oversight presents a significant risk of product contamination. In response to these findings, Omega Laboratories Ltd. is expected to address these operational and equipment design shortcomings. The company must implement comprehensive corrective and preventive actions to ensure the sterility and quality of its drug products, thereby maintaining compliance with regulatory standards for sterile manufacturing.