FDA 483 - Bestco LLC - May 13, 2019

Bestco, Inc. in Mooresville, NC, an OTC drug manufacturer, received a Form FDA 483 following an inspection from May 13-17, 2019. The inspection revealed significant deficiencies in quality control, including inadequate written procedures for raw material sampling, failure to conduct annual product reviews, and non-adherence to written production and process control procedures. These observations indicate a lack of robust quality management systems.