FDA 483 - Moehs Catalana SL - May 18, 2018

An FDA inspection of Moehs Catalana S.L. in Rubi, Barcelona, revealed deficiencies in their quality control unit. The firm failed to properly calibrate HPLC analytical equipment to cover all testing wavelengths and lacked a formal risk assessment for swab sampling locations during cleaning validation. These issues indicate a failure to fully adhere to established responsibilities and procedures within the quality control unit.