FDA 483 - Biotika a.s. - June 01, 2018

An FDA inspection of Biotika A.S., an API manufacturer in Slovenska Lupca, Slovakia, revealed significant deficiencies in documentation practices. Observations included incomplete batch production and control records, specifically regarding in-process test results, cleanroom parameters, and water volumes. The firm also failed to adequately document changes to computerized systems, review audit trails, and control user roles, indicating serious data integrity concerns.