FDA 483 - Northern Labs Inc - February 06, 2025

An FDA inspection of Northern Labs, Inc. in Manitowoc, WI, a contract manufacturer, revealed significant deficiencies in quality control. The firm failed to adequately test components for microbiological contamination, specifically by relaxing identification criteria for microorganisms in bulk water without scientific justification. Additionally, the company did not follow established change control processes for major facility modifications, including the construction of a new microbiology lab and a new filling line.