FDA WARNING_LETTER - Surgery Pharmacy Services Inc - December 06, 2019

On October 9, 2020, the FDA issued a Warning Letter to Surgery Pharmacy Services, Inc., following an inspection from November 18 to December 6, 2019. The inspection revealed serious deficiencies in the production of sterile drug products, leading to adulterated drugs under FDCA Section 501(a)(2)(A).

Key violations included: 1. Inadequate product evaluation and remedial actions for microbial contamination in the ISO 5 aseptic processing area. 2. Poor aseptic processing practices, such as personnel handling trash and resuming operations without changing gloves/sleeves, exposed skin in the ISO 5 area, and failure to disinfect supplies between air quality transitions. 3. A worn, stained, and chipping laminate work surface in the ISO 5 area. 4. Media fills not performed under challenging conditions, lacking assurance of aseptic production. 5. Use of non-sterile disinfectant in the ISO 5 area. 6. Failure to perform adequate dynamic smoke studies to demonstrate unidirectional airflow in the ISO 5 area.

The FDA reviewed the firm's December 26, 2019, response but found some corrective actions insufficient due to lack of documentation, specifically regarding revised media fill assessments and the status of the decommissioned laminate hood. The FDA strongly recommended a comprehensive assessment of operations, including aseptic processing, with assistance from a third-party consultant. The firm must respond within fifteen working days with specific