FDA 483 - Chugai Pharma Manufacturing Co. Ltd. (CPMC)

Chugai Pharma Manufacturing Co., Ltd. in Kita-ku, Tokyo, Japan, a drug substance manufacturing facility, received an FDA Form 483 for multiple significant deficiencies. Observations included untimely resolution of deviations, approval of raw materials before complete testing, and inadequate Standard Operating Procedures. Further issues involved insufficient equipment cleaning validation, deficient controls for defective materials, inadequate environmental cleaning, poor preventative maintenance, and incomplete master batch records.