FDA 483 - PRIMROSE CANDY CO - November 19, 2021

An FDA inspection of Primrose Candy Company in Chicago, IL, revealed numerous significant deficiencies in their manufacturing and quality control processes for OTC menthol lozenges. The firm failed to conduct thorough investigations into failed batches, maintain adequate laboratory records, establish stability programs, and validate manufacturing processes. Many of these issues were repeat observations from previous inspections, indicating persistent non-compliance with good manufacturing practices.