Arch Chemicals, Inc. – FDA 483

ARCH CHEMICALS, INC. in Rochester, NY, an API manufacturer, was cited with six observations during an FDA inspection from July 22-24, 2025. The inspection revealed significant deficiencies in quality control, including inadequate investigations of out-of-specification results, an insufficient stability testing program for APIs, and poor equipment cleaning practices. Additionally, the firm failed to ensure scientifically sound test procedures, record quality activities contemporaneously, and maintain complete and secure laboratory control records, indicating a broad lack of adherence to good manufacturing practices.