FDA EIR - PRIMROSE CANDY CO - February 25, 2021

An FDA inspection of Primrose Candy Company, a Chicago-based manufacturer of food, dietary supplements, and OTC drugs, was conducted on February 18, 22, and 25, 2021. The inspection focused on food and dietary supplement operations, carried out under Compliance Programs 7321.008 and 7303.040, which govern dietary supplement and preventive controls for human food operations. The inspection resulted in a two-item FDA Form 483, detailing significant observations. Firstly, the company failed to adequately maintain equipment and utensils used in manufacturing dietary supplements, with metal chipping and damage noted on various pieces of machinery, including kettles and mixers. This observation was further underscored by a concerning trend of ten metal-related consumer complaints in 2020, which lacked proper investigation and root cause analysis. Secondly, Primrose Candy Company did not adhere to its written quality control procedures, specifically failing to develop and utilize internal specifications for raw materials such as Glucosamine and Chondroitin, relying instead on supplier documentation. Additionally, several issues were discussed with management, including incomplete batch records for dietary supplements, illegible labeling on secondary containers, foreign material observed in product boxes, and electronic records not being readily available. Primrose Candy Company was advised to submit a formal written response to the FDA-483 within 15 business days. Management acknowledged the findings and indicated plans to establish a maintenance program for equipment.