Cuxhaven, Germany, 14 March 2011 - Concerning the recent contamination of vitamins with chloramphenicol (CAP), the route of entry of the CAP at the manufacturing company XIAMEN Kingdomway Group Company, Xiamen/Fujian, PR China (“KDW”) was investigated by a Lohmann Animal Health QM task force from Germany on site under full support and transparency of the manufacturer KDW.
The instruments of quality management according to ISO 9001 are in place as audited in purchasing, production, export & sales, human resources and quality control/quality assurance. A quality improvement plan for 2011 does exist. Since 17 January 2011 all deliveries of Vitamin A and D3 and since 1 February 2011 all products in general from China are tested for chloramphenicol before processing at Lohmann Animal Health. Only negatively tested material is shipped.
Findings: In the synthesis of vitamin A at KDW the substance methyl chloroacetate is a precursor. This raw material was supplied in drums by Changzhou Wujin Changshen Chemical Co. Ltd (CWC). This company also produces a similar substance, methyl dichloroacetate, which is used in the production of CAP, but not in vitamin A production. Since this substance is used as a reagent in the final step of the CAP synthesis, the drums have potential contact with CAP. The drums in which these substances are shipped are part of a recycling system. CAP and vitamin A are produced by different companies. The contamination appeared to be caused by cross contamination. Based on findings, no CAP was found in Vitamin D3.
On site methyl chloroacetate containing drums were tested positive on CAP. The drums were only rinsed with water prior to refilling them. The supplier of the raw material agreed with the vitamin producer to only use new packaging from now on.
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