FDA EIR - Ajinomoto Althea, Inc. - December 20, 2019

A pre-license inspection of Ajinomoto Althea, Inc., located at 11040 Roselle St, San Diego, CA, was conducted by the FDA from December 16 to December 20, 2019. This inspection supported the approval of specific drug products and was carried out in accordance with regulatory frameworks such as CPGM 7356.002M, CPGM 7346.832, and ICH Q7. The inspection resulted in three significant observations documented on an FDA-483 form. The main issues identified were: procedures designed to prevent microbiological contamination of sterile drug products were either not written or not followed, aseptic processing areas had deficiencies in their environmental monitoring processes, and equipment and utensils were not adequately cleaned and maintained to prevent product contamination. Management committed to providing a formal response to these observations within 15 business days. The inspection concluded with a field recommendation of Voluntary Action Indicated (VAI), suggesting that while corrective actions are necessary, the issues do not warrant severe regulatory enforcement, and also recommended approval for the specified drug products.