FDA 483 - Denver Solutions, LLC DBA Leiters Health - April 05, 2024

An FDA inspection conducted from March 20 to April 5, 2024, at Denver Solutions, LLC DBA Leiters Health, an outsourcing facility in Englewood, CO, identified significant deviations from regulatory requirements, with several issues being repeat observations from a 2021 inspection. The main violations centered on a pervasive failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results, encompassing inadequate investigations for potency and endotoxin OOS, insufficient microbial testing during adverse drug reaction investigations, and delayed resolution of potency deviations. The firm also demonstrated deficiencies in establishing, writing, and following procedures to prevent microbiological contamination, evidenced by inadequate smoke studies for aseptic processing, observed poor aseptic techniques by personnel, and the release of product batches despite positive microbial growth on operator sleeves. Further issues included the quality unit's inadequate implementation of corrective and preventive actions, a failure to adhere to the written stability testing program (e.g., using extended Beyond Use Dates without sufficient data), and inconsistent cleaning and maintenance of equipment. Furthermore, both container and drug product labels lacked essential information, specifically the dosage form, as mandated by Sections 503B(a)(10)(A) and (B) of the Federal Food, Drug, and Cosmetic Act. Leiters Health is required to address these systemic issues to achieve compliance with federal regulations and good manufacturing practices.