FDA 483 - SV Labs Prescott Corporation - September 28, 2018

Diversified Manufacturing Corporation in Prescott, WI, a manufacturer of human and animal drugs, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight severe breakdowns in quality control, including failure to reject out-of-specification products and inadequate investigation procedures. Additionally, the firm exhibited critical issues in laboratory controls, equipment qualification, data integrity, and labeling management, indicating a pervasive lack of adherence to current good manufacturing practices.