FDA EIR - Ajinomoto Althea, Inc. - November 15, 2013

Ajinomoto Althea, Inc. underwent an FDA Pre-Approval and Current Good Manufacturing Practice (CGMP) inspection from November 4-15, 2013, focusing on its role as a contract manufacturer of clinical and biological drug products. The inspection identified twelve significant deficiencies across several critical operational systems. In the Laboratory Control System, the company failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods. Scientifically sound specifications for materials and drug products were absent, and in-process specifications were inconsistent with final product standards. The stability program was inadequate, notably not supporting tentative expiration dates with ongoing full-shelf studies and failing to test products in their final container-closure systems. Furthermore, supplier analysis reports for components were accepted without proper validation, and representative samples were not consistently taken for incoming materials. Deficiencies in the Production System included batch records that omitted actual and theoretical yield percentages, alongside master production records lacking complete manufacturing and control instructions. The Facilities and Equipment System exhibited issues with inadequate air pressure control and equipment designs unsuitable for their intended use, cleaning, and maintenance. These violations were cited under applicable regulatory frameworks, including CGMP regulations. Following the issuance of an FDA-483 form to the President/CEO, Ajinomoto Althea committed to implementing corrections and submitting a formal written response to the District within fifteen working days.