FDA 483 - Safeway, Inc. - June 12, 2017

During an inspection conducted by the Food and Drug Administration (FDA) from June 5 to June 12, 2017, Safeway, Inc. in San Jose, CA, received a Form FDA 483 detailing observed deficiencies. The inspection focused on the firm's operations as a producer of non-sterile and sterile drugs, identifying concerns primarily within its aseptic processing areas. The main observation highlighted that the company's aseptic processing areas lacked adequately smooth and hard surfaces, making them difficult to clean, which is critical for maintaining sterility and preventing contamination in drug manufacturing. Specifically, inspectors noted two-inch cracks in the plexiglass side panels within the ISO 5 cleanroom area of a Laminar Flow Hood. Additionally, two two-foot long fluorescent light bulbs and their associated electrical wiring units were found exposed in the upper corners of the laminar flow hood due to missing covers. These observations indicate a departure from current Good Manufacturing Practice (cGMP) requirements, which mandate appropriate facility design and maintenance to ensure product quality and safety. While the FDA 483 itself does not dictate specific corrective actions, it serves as a notification of objectionable conditions that require the company's attention. Safeway, Inc., through its Pharmacist in Charge, Ms. Karen L. Muir, is expected to address these findings and implement suitable corrective and preventive actions to rectify the observed deficiencies and ensure compliance with regulatory standards.