483
AQUISEL S.L.U.AQUISEL S.L.U. – FDA 483, May 15, 2019
Record Details
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.
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ID · 620e1f35-c4de-44ae-af9a-44e7e82f9392
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