FDA 483 - Biokit, S.A. - July 11, 2022

An FDA inspection of Biokit S.A. in L'lissa D'Amunt (Barcelona), Spain, revealed significant quality system deficiencies. Observations included inadequate design verification failing to confirm design output meets input, a lack of established procedures to control non-conforming products, and the use of obsolete documents in active processes. These issues indicate a need for improved quality management practices at the device manufacturing facility.