FDA 483 - Anhui Hanbon Daily Chemical Co., Ltd. - March 28, 2025

During an FDA inspection from January 23 to February 17, 2017, Hospira Inc., a drug manufacturer in McPherson, KS, received a Form 483 detailing significant observations. The inspection revealed a failure to establish and follow production and process control procedures, leading to recurring contamination of sterile drug products with foreign particulate matter, such as stainless steel and iron oxide, since 2015. Corrective actions for these issues were frequently ineffective. Additionally, the firm demonstrated deficiencies in preventing microbiological contamination, with multiple instances of mold and bacteria in its aseptic processing line where investigations often failed to identify root causes. The company's quality control unit was found lacking in ensuring thorough investigations, implementing effective corrective actions, and completing equipment-related investigations. Procedures for cleaning and maintenance of aseptic processing areas and equipment were not consistently followed or adequately documented. Furthermore, laboratory controls for detecting particulate matter were not validated, and no comprehensive defect library was established for inspector training. Hospira Inc. must address these critical observations to ensure the quality, purity, and safety of its sterile drug products and to comply with regulatory standards.