FDA EIR - Ajinomoto Althea, Inc. - August 07, 2019

An FDA for-cause inspection of Ajinomoto Althea, Inc., operating as Ajinomoto Biopharma Services, a sterile injectable drug manufacturer in San Diego, CA, was conducted from July 30 to August 7, 2019. The inspection, carried out under FDA Compliance Programs for drug process and quality systems, followed up on issues from a prior March 2019 inspection that cited inadequate deviation investigation, lack of quality oversight, and insufficient clean hold time studies. This inspection specifically focused on a history of lots exceeding action limits for particles, identified between August 2017 and March 2018, stemming from sources like stainless steel trays, stoppers, capping equipment, and oxidized stainless steel connectors. Despite some corrective actions, a two-item FDA-483 was issued. The main violations included: 1) The Quality Control Unit failing to consistently reject drug product lots associated with faulty connectors and corroded stainless steel particulates. Affected injectable lots were not always rejected, even when linked to a confirmed root cause of corroded components within connection fittings. 2) Investigations into unexplained discrepancies or batch failures, such as the stainless steel particulate issue, did not consistently document the assessment of impact on other batches of the same drug product or other potentially affected drug products, as required by cGMP investigation procedures (21 CFR 211). Ajinomoto Althea's management committed to submitting a written response to the FDA-483 observations within 15 business days. While some prior deficiencies from the March 2019 inspection were corrected, issues related to quality agreements, clean hold time studies, and conveyor airflow visualization remained in progress or partially corrected.