FDA 483 - PRIMROSE CANDY CO - February 25, 2021

Primrose Candy Company, a manufacturer of candy, dietary supplements, and OTC drugs in Chicago, IL, received a Form 483 for two significant observations. The firm was cited for failing to maintain equipment and utensils, with metal chipping and damage observed on manufacturing equipment, which was linked to consumer complaints. Additionally, the company did not follow its own written procedures for quality control operations, specifically regarding the development of internal raw material specifications for dietary supplements.