Challenge Bioproducts Company, Ltd. – FDA 483, Oct 31, 2022

Challenge Bioproducts Company, Ltd. in Tou-Liu City, Taiwan, received a Form 483 citing significant deficiencies in quality assurance, facility and equipment cleaning, and in-process sampling. Issues included inadequate deviation investigations, unverified analytical methods, lack of cleaning validation, and unsanitary sampling practices. These observations indicate a high risk of product adulteration and lack of control over manufacturing processes.