FDA 483 - SpecGx LLC - September 09, 2019

SpecGx, LLC in Saint Louis, MO, was cited for significant deficiencies during an FDA inspection, including repeat observations regarding inadequate investigations of critical deviations and batch failures. The firm also failed to maintain adequate controls over computerized systems and did not submit required NDA-Field Alert Reports for distributed drug product issues. These findings indicate a systemic lack of control over quality processes and data integrity.