Audit Report

Ajinomoto Saga-Gun JA – 825

Audit #: JA - 825
Region: Japan
Material: API/ExcipientsBasic Chemicals/Raw Materials
Company: Ajinomoto
Location: 450 Morodomi-Tsu, Morodomi- Cho Saga- Gun Saga- Ken 840-2193
Date: 22-23 June 2016

This Rx-360 Audit Report contains the following scope:

The scope of the audit included the manufacture, packaging, testing, warehousing and
distribution of below materials:
 L-Arginine
 L-Arginine Monohydrochloride
 L-Glutamic Acid
 L-Lysine Monohydrochloride
This audit was based on the Rx-360 Audit Guideline for Pharmaceutical Excipients v2.0,
Rx-360 Audit Guideline for Basic Chemicals and Raw Materials v2.0 and the Rx-360 Supply
Chain Security Checklist 2.0.
Aforementioned materials are manufactured as pharmaceutical excipients and basic chemicals
and raw materials. The whole production (from starting material to release of the finished
product) is performed at Ajinomoto Co., Inc. Kyushu Plant