FDA 483 - Strive Pharmacy Texas LLC dba Strive Pharmacy - February 11, 2020

An FDA inspection conducted between January 22 and February 11, 2020, at Vita Pharmacy, LLC, doing business as Talon Pharmacy of Boerne, revealed significant deficiencies in their production of sterile and non-sterile drugs. The observations, detailed in an FDA Form 483, indicate several failures in adhering to Good Manufacturing Practices. Key issues included poor aseptic practices during sterile drug production, such as operators failing to re-sanitize gloved hands after reaching outside the critical ISO 5 area and performing sterile operations outside certified workspaces. Furthermore, critical sterile supplies were stored in open packaging. The facility also failed to properly depyrogenate glass beakers used for sterile injectables, cleaning them with household detergent and using them interchangeably for hazardous non-sterile products. A brownish residue was noted on an ISO 5 HEPA filter. The cleanroom certification was found to be inadequate, lacking dynamic condition testing, showing turbulent airflow, and not extending smoke studies to the entire ISO 7 area. Environmental monitoring was not performed. Critically, the firm produced hazardous, highly potent drugs without proper containment, leading to a risk of cross-contamination, and used an unverified cleaning agent for shared equipment and surfaces. Talon Pharmacy of Boerne must implement comprehensive corrective actions to address these serious deviations and ensure patient safety and product quality.