FDA 483 - SpecGx, LLC - January 17, 2025

SpecGx LLC in Hobart, NY, was cited for significant deficiencies across four observations during an FDA inspection. The firm failed to control microbiological quality of raw materials, exhibited poor laboratory control mechanisms including dissolution apparatus issues and cross-contamination risks, and lacked adequate air pressure control in production rooms. Additionally, the company's cleaning validation methods for equipment were found to be unvalidated for microbial recovery, indicating a systemic issue with contamination prevention.