FDA 483 - Surgery Pharmacy Services, Inc. - December 06, 2019

The FDA inspection conducted at Surgery Pharmacy Services, Inc. from November 18 to December 6, 2019, identified significant deficiencies in their sterile drug production processes. These observations, documented on an FDA Form 483, indicate a lack of adherence to regulatory standards for manufacturing sterile products. Major issues included inadequate responses to microbial contamination in ISO 5 critical areas, where proper patient impact assessment and notification were omitted. Personnel exhibited poor aseptic technique, failing to disinfect gloves sufficiently or maintain full gowning integrity, with exposed skin observed during production. Furthermore, disinfection protocols for materials entering aseptic processing areas were found deficient, and non-sterile agents were improperly used in ISO 5 hoods. The inspection also noted critical failures in quality control and environmental monitoring. Media fills did not adequately simulate worst-case production scenarios, and pressure differentials in classified areas were not properly monitored. The firm released drug products, specifically epinephrine irrigation solutions, despite failing assay tests for strength and purity, and lacked supporting documentation for assigned Beyond-Use Dates. Physical infrastructure also posed risks, with worn and stained surfaces in ISO 5 hoods. Finally, ISO 5 areas lacked dynamic certification under challenging operational conditions, indicating potential airflow compromise. Surgery Pharmacy Services, Inc. is required to address these systemic issues by implementing robust corrective and preventive actions to ensure compliance with cGMP regulations, thereby safeguarding the quality and safety of their sterile drug products.