FDA 483 - Blue Sea Aerosol & Daily Care Co., Ltd - October 31, 2025

During an inspection conducted from October 27-31, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Blue Sea Aerosol and Daily Care Co., Ltd., a drug manufacturer in Hebei Province, P.R. China. The observations detail significant deficiencies indicating non-compliance with current Good Manufacturing Practices (cGMP) under the Federal Food, Drug, and Cosmetic Act. Key violations include inadequate laboratory controls, where the company's quality unit failed to perform identity testing on raw materials for OTC drug products, relying solely on organoleptic tests and supplier Certificates of Analysis. The unit also neglected to assess impurity risks in raw materials and did not adequately verify the suitability of microbiological media through pH checks or growth promotion testing. Additionally, the inspection revealed severe issues with equipment maintenance and cleaning. Inspectors observed apparent rust, corrosion, black particles, and shedding debris on the filling line for OTC drug products. This equipment had not been sufficiently cleaned or maintained, with the last cleaning reported several months prior to the inspection. Equipment qualification also lacked the identification of key process parameters. The company is required to promptly address these observations by implementing comprehensive corrective actions to ensure the safety, identity, strength, quality, and purity of drug products.