Inspection status

Esteve Química's Quality System has been regularly inspected by national authorities, with the first FDA inspection being conducted in 1978 (35 inspections of the agency have been performed since that date).


The last inspections conducted at each manufacturing site were:

Inspection status
Location Site Authority
FDA USA AEMPS / Generalitat Spain KFDA (MFDS) Korea PMDA Japan COFREPRIS Mexicos CFDA/NMPA China MHRA UK
Europe Celrà manufacturing site, Spain February 2019 April 2018 April 2015 April 2007
Europe Banyeres manufacturing site, Spain June 2017 March 2019 December 2011
Asia EHP manufacturing site, China January 2019 May 2011 June 2017 May 2018 March 2019 July 2019
America Jiutepec manufacturing site, Mexico July 2017 September 2010 May 2013 June 2018