FARMAKEIO OUTSOURCING LLC – FDA 483, Aug 18, 2025

An FDA inspection conducted at FARMAKEIO OUTSOURCING LLC in Southlake, TX, from August 18 to September 5, 2025, identified significant deficiencies in the firm"s manufacturing processes and quality control systems. The observations highlight failures to comply with good manufacturing practices for an outsourcing facility. Key issues included a lack of thorough investigation into critical discrepancies. For instance, the firm inadequately investigated metal shavings found in Testosterone/Triamcinolone Acetonide granulation, failing to assess the full impact on distributed sterile pellets, especially given their metal detection system was not fully operational. Customer complaints regarding cracked or incorrect pellets were also not adequately addressed. Laboratory controls were found deficient, with the firm distributing Testosterone/Triamcinolone Acetonide pellets containing unidentified chemical peaks and failing to establish appropriate specifications for active ingredient addition. Moreover, the company did not conduct required dissolution testing for multiple controlled-release pellet product families, impacting assurance of consistent drug release. Equipment validation was also cited, specifically regarding an inadequate qualification protocol for the metal detection system. These observations indicate a need for FARMAKEIO OUTSOURCING LLC to implement comprehensive corrective actions, including robust investigations, updated laboratory and manufacturing controls, and proper equipment qualification, to ensure product quality and patient safety.