Audit Report

DSM Nutritional Products AG – JA – 786

Audit #: JA - 786
Region: Switzerland
Material: API/Excipients
Company: DSM Nutritional Products
Location: Werk Siseln, Hauptstrasse 4 Sisseln Switzerland
Date: 26-27 June 2017

Rx-360 Audit Report contains the following scope:

The scope of the audit included the production, testing, packaging, storage and distribution of:
DL-Alpha Tocopheryl Acetate 0420085 (aka Vitamin E Acetate)
DL-Alpha Tocopherol 0410276
Vitamin D3 1.0 MIU/G 0419133264
Dry vitamin D3 100 SD/S 5005043
Dry Vitamin D3 CWS 0418110 (aka Vitamin D3 100CWS)
Vitamin A Palmitate 1.0 MIU/G (stabilized with tocopherol) 0431400
Vitamin A Acetate 2. 03 MIU/G 0423009
Dry Vitamin A Palmitate 250 CWS/F (tocopherol) 0421871
Dry Vitamin A Palmitate Type 250 CWS (BHA/BHT) 0429937
Dry Vitamin A Palmitate Type 100 WS (tocopherol) 0429570
Folic Acid 0417823
Βeta Carotene 1%CWS/M 5003741
Betatab 10% E 0434140
Beta Carotene 20% ( CaroCare Nat. Beta Carotene 20% CWS/S-TG),
Apocarotenal 1% CWS/M 5006317
Lycopene 10% (Lycopene 10% CWS/S-TG 5003792 and Lycopene 10% WS 0481041),
Lutein 5% CWS/S-TG 5005213
Cantaxantin 10 CWS/S 5005256
Coenzyme Q10 10% CWS/S 5004160
Dry Vitamin K1 5% SD 0434922
Vitamin B12 1% SD 5012511 (aka Vitamin B12 Cyanocobalamin)
Vitamin B12 0.1% WS 0429090
Vitamin A Palmitate 1.7 MIU/g without stabilizers 0424005
Vitamin A Palmitate 1.7 MIU/g stabilized with tocopherol 0418579
Vitamin A Palmitate 1.7 MIU/g stabilized with BHA/BHT 0424013
Dry vitamin E 50% CWS/S 5001129
as well as security aspects.
The audit was based on Rx-360 Consortium guidelines for APIs and Excipients and supply chain
security component based on the Rx-360 Consortium Supply Chain Security Checklist