FDA 483 - empower clinic services, llc, - November 03, 2025

An FDA inspection conducted between November 3 and November 14, 2025, at Empower Clinic Services, LLC, operating as Empower Pharmacy, a producer of sterile and non-sterile drug products in Houston, TX, resulted in six significant observations documented on Form FDA 483. The inspection highlighted critical deficiencies in the firm"s sterile manufacturing processes and environmental controls.Key issues included the presence of microbial contamination in an ISO-classified filling room, leading to a batch of Testosterone Cypionate being processed and dispensed despite exceeding environmental monitoring action limits. Repeat observations noted failures in appropriately and regularly cleaning and disinfecting equipment, such as scissors and iPads, within ISO areas, and a lack of disinfection protocols for items like pens used by multiple technicians.Furthermore, personnel were observed disrupting critical "first air" during aseptic manipulations and moving too rapidly in critical areas, potentially compromising unidirectional airflow. The firm"s smoke studies were deemed inadequate as they did not fully simulate dynamic conditions, including equipment setup and cleaning interventions. A crucial deficiency identified as a repeat observation involved the failure to conduct media fills that accurately reflect actual production batch sizes and worst-case scenarios, such as the volumes used for Tirzepatide/Niacinamide injections.These observations indicate a need for comprehensive corrective and preventive actions to ensure compliance with current Good Manufacturing Practices and prevent potential compromise of drug product sterility and quality.