PRIMROSE CANDY CO – FDA EIR, Nov 19, 2021

An FDA surveillance inspection was conducted at Primrose Candy Co. in Chicago, IL, from November 15-19, 2021. The inspection, carried out under FDA's drug manufacturing compliance program, focused on the company's over-the-counter (OTC) menthol lozenge drug product line, specifically reviewing quality, materials, facilities, equipment, and laboratory control systems. The regulatory framework for this inspection was the Federal Food, Drug, and Cosmetic Act, emphasizing current good manufacturing practices.The inspection revealed 12 significant deficiencies, many of which were repeat observations from previous inspections. Key issues included a failure to investigate out-of-specification menthol assay results, inadequate laboratory controls such as insufficient system suitability testing, improper storage of reference standards, and incomplete laboratory records. The company also lacked a written stability testing program to support product expiration dates and failed to verify the identity of incoming raw materials or validate supplier certificates of analysis. Furthermore, procedural shortcomings were identified, including unapproved and uncontrolled written procedures, production deviations without quality approval, and a lack of process validation studies for drug products. The company did not perform annual product reviews or routine visual examinations of reserve samples, and labels for OTC drug products were stored in an unsecured area.Primrose Candy Co. management was informed of their responsibility to comply with the Federal Food, Drug, and Cosmetic Act. They committed to submitting a written response to the FDA within 15 days detailing proposed corrective actions. Failure to address these deficiencies could lead to regulatory actions such as product seizure or injunctions.