FDA 483 - AQUISEL S.L.U. - May 15, 2019

AQUI-SEL, S.L.U. in Abrera, Barcelona, Spain, a manufacturer of Class 2 medical devices, was inspected by the FDA from May 13-15, 2019. The inspection revealed deficiencies in the firm's quality system, specifically regarding the lack of established statistical techniques for sampling plans and the use of unapproved documents. These observations indicate a need for improved quality control and document management practices.