UPDATE: WHO Position paper on Qinhuangdao Zizhu Pharmaceutical Co Ltd, Active Pharmaceutical Ingredient (API) manufacturing site following the issue of the USFDA import alert

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13 February, 2018 - 12:00 (CET)

Alerts

On 07 April 2017, WHO issued a position paper on the import alert placed on, Qinhuangdao Zizhu Pharmaceutical (QZP) by the United States Food and Drug Administration (USFDA) on 8 March 2017. This followed an inspection carried out by the USFDA at Qinhuangdao Zizhu Pharmaceutical, No. 10, Longhai Avenue, Economic Development Zone, Qinhuangdao, Hebei, China 066004 from 28 November to 01 December 2016. The inspection identified failures in the level of adherence to cGMP for APIs. In particular, the USFDA inspection team discovered serious breach of data integrity.

What has WHO done since issuing the position paper?

The WHO Prequalification Team (PQT) reviewed corrective and preventive actions (CAPAs) undertaken by the company and performed a for cause inspection at QZP in December 2017. The objective of this inspection was to verify the implementation of CAPAs undertaken by QZP as committed to USFDA.

For more information, see below document: "Update on WHO Position paper on Qinhuangdao Zizhu Pharmaceutical Co Ltd" (13 February 2018)

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