FDA 483 - Denver Solutions, LLC DBA Leiters Health - November 13, 2025

During an inspection conducted from November 13 to December 11, 2025, the FDA identified significant manufacturing deficiencies at Denver Solutions, LLC, an outsourcing facility located in Englewood, CO. The inspection revealed multiple violations of good manufacturing practices (GMP) detailed in a Form FDA 483.Key issues included a lack of adequate written procedures for production and process controls, specifically concerning the aseptic filling process for Bevacizumab 25 mg/ml injection. The validation of this critical process was deemed insufficient, with the firm relying on post-production filtration to salvage failing batches due to contamination and sub-visible particulates. Equipment used in aseptic filling was also found to be inadequately designed, with a product-contact component confirmed to leach into the drug, contributing to recurring out-of-specification results for particulates without proper initial qualification.Furthermore, the facility"s environmental monitoring system was deficient, lacking scientifically sound sampling methods, risk assessments for representativeness, and proper placement or orientation of particle monitoring probes. There was also an absence of documented justifications for in-process control sample sizes, particularly for products in opaque containers. The aseptic process validation was inadequate, with critical ISO cleanroom areas not certified or re-certified under dynamic conditions. Finally, the cleaning and disinfecting procedures were found to be insufficient, with incomplete disinfectant efficacy studies and observed rust on equipment in an ISO cleanroom. Denver Solutions, LLC is required to address these observations by implementing comprehensive corrective actions to ensure compliance with regulatory standards.