FDA 483 - SGS Chemical Solutions Laboratories Inc. - August 22, 2018

Chemical Solutions Ltd. in Harrisburg, PA, a control testing lab, was cited for two significant observations during an FDA inspection. The firm failed to exercise appropriate controls over computer systems, allowing analysts to delete and alter electronic raw data without an audit trail, which was noted as a repeat observation. Additionally, laboratory records were found deficient, lacking proper documentation for sample receipt, quantity, and disposal for both non-controlled drug products and finished products.