FDA 483 - Rhodes Pharmaceuticals, L.P. - September 26, 2025

During an FDA inspection conducted from September 23-26, 2025, Rhodes Pharmaceuticals, L.P. was cited for multiple deficiencies indicating non-compliance with Good Manufacturing Practices. Key issues included a failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results, particularly recurring analyst errors in sample handling and insufficient impact assessments following equipment malfunctions. Laboratory controls were found inadequate, with analysts performing excessive test injections without proper management authorization and controlled substance samples awaiting disposition without documented quality status. The quality unit also failed to fully adhere to its own written procedures, notably lacking complete batch cleaning records for critical manufacturing areas and equipment. Furthermore, batch production and control records were incomplete, showing no reconciliation for rejected bottles from packaging lines post-checkweigher implementation, absent documentation for checkweigher challenge standards, and unrecorded critical process alarms. Equipment and utensils were not consistently cleaned and maintained, evidenced by damaged components on a filler’s HMI screen and dust buildup on equipment with exposed product-contact surfaces in a "Ready for Use" room. Finally, the facility itself showed maintenance issues, with a taped ceiling in a primary packaging area not captured in line clearance documentation. Rhodes Pharmaceuticals must promptly address these observations to ensure compliance with federal drug manufacturing regulations.