PALMETTO ISOTOPES, LLC – FDA 483, Feb 28, 2025

During an inspection conducted from February 19 to February 28, 2025, the FDA issued a Form 483 to PALMETTO ISOTOPES, LLC, a nuclear pharmacy in Ridgeland, SC, citing significant observations related to its sterile radiopharmaceutical production. The inspection highlighted several deviations from good manufacturing practices.Key issues included inadequate routine environmental monitoring, specifically the absence of viable air monitoring in ISO 5 primary engineering controls. The firm also failed to conduct media fills that accurately simulate its aseptic syringe production, and some operators did not perform media fills for all critical equipment. Furthermore, smoke studies, crucial for demonstrating unidirectional airflow, were not performed under dynamic conditions, lacking documented evidence.Additional concerns involved unsanitary conditions, such as a dirty HEPA filter grid and hard-to-clean items within an ISO 5 primary engineering control. Personnel were observed wearing non-sterile gloves during aseptic processing, and the facility demonstrated improper use of sporicidal agents, failing to disinfect return dose containers (pigs) adequately. These observations indicate a need for comprehensive corrective actions to ensure the sterility and quality of products, aligning with regulatory expectations under the Federal Food, Drug, and Cosmetic Act. The company is expected to address these deficiencies.