FDA 483 - Denver Solutions, LLC DBA Leiters Health - October 07, 2021

During an inspection from September 23 to October 7, 2021, the FDA observed significant deficiencies at Denver Solutions, LLC, operating as Leiters Health, an outsourcing facility. The inspection, documented in an FDA 483, highlighted critical issues primarily related to manufacturing controls and quality systems, indicating non-compliance with Current Good Manufacturing Practices (CGMP).

Key violations included a pervasive failure to thoroughly investigate unexplained discrepancies. Numerous batches of sterile products like Lidocaine, Phenylephrine, Fentanyl Citrate, and Bevacizumab were found with visible particles and fibers, both internally during visual inspection and through customer complaints. However, investigations were inadequate and failed to implement corrective actions. Environmental monitoring deviations were also not fully investigated, and a policy limited investigations unless deviations were recurring.

Aseptic processing areas exhibited multiple deficiencies, including inadequate validation (smoke studies showing turbulent airflow), inconsistent disinfection procedures (lack of specified contact times), and improper material transfer between controlled environments. Operators' movements and ill-fitting protective gear (goggles with openings) also posed contamination risks. Environmental controls were further compromised by deficient air supply, evidenced by numerous negative pressure alarms in critical ISO 5/7 rooms without subsequent investigations.

Laboratory controls were found lacking, specifically in how out-of-specification (OOS) results were handled; procedures permitted re-testing and reporting passing results as final without conclusive root cause determination for initial OOS. Additionally, the firm failed to record deviations for confirmed potency OOS due to weighing errors. Finally, physical controls for rejected materials were inadequate, with an unlocked and unattended cage containing compounded products. Leiters Health is required to promptly address these serious observations to ensure product quality and patient safety.