FDA EIR - Microbac Laboratories, Inc. - July 10, 2015

An FDA surveillance inspection of Microbac Laboratories Inc., Wilson Division, was conducted from July 6-10, 2015, under Compliance Program 7356.002, Drug Manufacturing Inspections. The inspection, classified as 'No Action Indicated,' focused on the company's Quality and Laboratory Control Systems, relevant to their contract testing services for pharmaceutical, agrochemical, and other commodities under the FD&C Act. While no official Form FDA 483 was issued, several significant issues were discussed with management. These included eight Out-of-Specification investigations in 2014 that exceeded closure deadlines without proper extensions or deviation reporting. Furthermore, a January 2015 dissolution apparatus calibration failure lacked adequate documentation, and its pass/fail status was unclearly recorded. The inspection also noted a lack of defined deadlines within Corrective and Preventive Action (CAPA) procedures, recommending tighter, more rational timeframes. A critical observation concerned an IT access error, discovered in May 2015, which had granted chemistry analysts unauthorized data deletion capabilities in the chromatography system. The subsequent internal investigation was deemed insufficient for not comprehensively searching for potential data deletions from April 28 to May 22, 2015. Management committed to addressing these observations to ensure ongoing regulatory compliance.