FDA EIR - Ajinomoto Company Inc. - November 08, 2019

An FDA inspection of Ajinomoto Company Inc.'s Kawasaki Plant in Japan took place from November 5 to November 8, 2019. This abbreviated Good Manufacturing Practice (GMP) inspection focused on Active Pharmaceutical Ingredient (API) processes, adhering to Compliance Program 7356.002F. The regulatory framework requires adherence to current GMPs for drug products, as per section 501(a)(2)(B) of the Food, Drug and Cosmetic Act. While no formal FDA Form 483 observations were issued, several deficiencies were discussed verbally with management. Main issues included inadequate Out-of-Specification (OOS) investigations, particularly regarding incomplete root cause analysis and supplier engagement for certain impacted lots. A water puddle was also observed in a Class 100,000 cleanroom. Additionally, process validation procedures were deemed inadequate, lacking clear scientific rationale for determining the number of batches required during periodic revalidations. Required actions included the firm implementing procedural corrections, updating relevant Standard Operating Procedures, and providing additional training to address the OOS investigations and cleanroom environment issues. Management agreed to revise process validation SOPs to incorporate scientific rationale for batch numbers.