Audit Report

Seki sui Medical Co. Ltd JA – 806

Audit #: JA - 806
Region: Japan
Material: API/Excipients
Company: Seki sui Medical Co. Ltd JA - 806
Location: 4-115, Mastuo Hachimantai - Iwate 028-7305 Hachimantai
Date: 13-14 March 2017

This Rx-360 Audit Report contains the following scope:

The audit was primarily focused on the activities and systems involved in the manufacturing,
packaging, testing, warehousing and distribution of APIs of L-Methionine, N-Acetyl-LTyrosine,
Taurine, Arginine Glutamate and Excipients of Acetyl-DL-Tryptophan.
The audit was based on Rx-360 Audit Standards for Active Pharmaceutical Ingredients
(APIs) and API Intermediates (v1.0), and also included a supply chain security check based
on the Rx-360 Supply Chain Security Checklist (v2.0).