FDA 483 - Encore Scientific LLC - June 13, 2019

An FDA inspection of Encore Scientific LLC, an API re-packager in Broken Arrow, OK, revealed significant deficiencies in their quality control unit, record-keeping practices, and overall adherence to Good Manufacturing Practices. The firm failed to establish adequate written procedures for critical operations, ensure proper review and approval of batch records, and maintain appropriate controls over computer systems and equipment calibration. These issues indicate a systemic lack of control over their re-packaging and distribution processes.