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Inspection status

Esteve Química’s Quality System has been regularly inspected by national authorities, with the first FDA inspection being conducted in 1978 (31 inspections of the agency have been performed since that date).

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The last inspections conducted at each manufacturing site were:

Location	Site	Authority
		FDA USA	AEMPS / Generalitat Spain	KFDA (MFDS) Korea	PMDA Japan	COFEPRIS Mexico	CFDA China
Europe	Celrà manufacturing site, Spain	June 2017	June 2018	April 2015	May 2007
Europe	Banyeres manufacturing site, Spain	June 2017	June 2018	December 2011
Europe	Barcelona R&D Stability site, Spain	February 2015	June 2018
Asia	EHP manufacturing site, China	March 2015	May 2011	June 2017	May 2018		April 2018
America	Jiutepec manufacturing site, Mexico	July 2017	September 2010		May 2013	June 2018

Inspection status

Esteve Química’s Quality System has been regularly inspected by national authorities, with the first FDA inspection being conducted in 1978 (31 inspections of the agency have been performed since that date).

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