FDA EIR - Ajinomoto Althea, Inc. - March 22, 2019

An FDA pre-license inspection of Ajinomoto Althea, Inc., also known as Ajinomoto Bio-Pharma Services, was conducted from March 18 to March 22, 2019. This inspection supported Biologics License Applications for both a drug substance and a drug product, operating under the regulatory framework of FDA's Good Manufacturing Practice (GMP) for therapeutic drug products and active pharmaceutical ingredients, as outlined by the Food, Drug, and Cosmetic Act. The inspection covered quality, facilities, equipment, production, materials, and laboratory systems. While previous inspection deficiencies were verified as corrected, the current inspection resulted in a 3-item FDA Form 483, detailing new concerns. The main violations identified were inadequate deviation investigations, particularly regarding recurring incidents of broken vials where historical trends were not consistently assessed. The firm also demonstrated a lack of quality oversight, as crucial roles and responsibilities were not clearly defined in quality agreements with their drug substance and drug product sponsors. Additionally, the company failed to perform necessary clean hold time studies for a specific manufacturing system. In response to these observations, Ajinomoto Althea, Inc. management committed to submitting a formal reply within 15 business days, outlining their corrective actions.