FDA 483 - SpecGx, LLC - September 18, 2023

An FDA inspection of SpecGX, LLC in St. Louis, MO, conducted from September 11-15 and 18, 2023, revealed significant issues related to the manufacturing of human drug products. The company received a Form FDA 483, indicating potential deviations from Good Manufacturing Practices. Key observations included a lack of established written procedures to prevent objectionable microorganisms in non-sterile drug products and their manufacturing water. Specifically, SpecGX failed to test drug products and water for specific microorganisms like Burkholderia cepacia complex (BCC), conduct method suitability studies for BCC detection, and speciate microbial recovery in their water system. Additionally, the inspection highlighted a failure to thoroughly investigate unexplained discrepancies. An internal investigation into off-white residue on equipment used for Diphenoxylate Hydrochloride and Atropine Sulfate USP Tablets was found inadequate, as it did not include microbial or chemical contamination testing. Moreover, the firm continued manufacturing affected drug lots before a planned corrective action, involving equipment disassembly for cleaning, was formally implemented and documented. These observations underscore the need for SpecGX, LLC to implement robust corrective and preventive actions to ensure product quality and compliance with regulatory standards.