FDA 483 - Ajinomoto Althea, Inc. - August 07, 2019

On August 7, 2019, the FDA issued a Form 483 to Ajinomoto Althea, Inc., a sterile drug manufacturer located at 11040 Roselle St, San Diego, CA 92121-1205, following an inspection from July 30 to August 7, 2019. The report was issued to Kristin M. Defife, Sr. VP of Operations & Site Head.

The inspection revealed two observations:

1. **Lack of Quality Control Unit Authority:** The quality control unit, while having the responsibility and authority to approve and reject drug products, did not consistently reject lots associated with faulty connectors causing stainless steel corrosion particulates. For example, injectable drug product lots from January-February 2018, found to have a higher incidence of particulate rejects due to corroded components within connectors, were not always rejected.

2. **Inadequate Investigation Scope:** Investigations into unexplained discrepancies or batch failures did not consistently extend to other potentially affected batches or drug products. The firm's SOP-0980, Rev 000, "Conducting cGMP Investigations," requires assessing the impact on other processes, procedures, products, or patients. However, reviewed investigation reports did not always document this assessment, failing to confirm whether the investigation was extended to other similarly affected batches or drug products.