FDA EIR - Microbac Laboratories, Inc. - February 22, 2018

The FDA conducted a routine surveillance inspection of Microbac Laboratories, Inc. Wilson Division from February 20 to February 22, 2018. This inspection was performed under Compliance Program Guidance Manual 7356.002 for Drug Manufacturing Inspections, focusing on the firm's Quality and Laboratory Control systems. Microbac Laboratories operates as a contract laboratory, offering chemical and microbiological testing and research support services for various commodities, including pharmaceuticals, which fall under the scope of the U.S. Food, Drug and Cosmetic Act. The inspection concluded with positive findings, as no significant violations or objectionable conditions were observed. A Form FDA 483, Inspectional Observations, was not issued. The FDA investigator reviewed comprehensive documentation and procedures for both the Quality System and Laboratory Control System, including training, non-conformances, investigations, and method validations, finding them adequate. At the closeout meeting, management was reminded of their ongoing responsibility for compliance, with the understanding that while no immediate issues were found, continued adherence to regulatory standards is essential to avoid potential future sanctions.