Seki sui Medical Co. Ltd JA – 806
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).