SISLEY INDUSTRIE – FDA 483, Apr 19, 2024

An FDA inspection of Francos, an OTC drug manufacturer in Villebarou, France, revealed significant deficiencies in laboratory controls and quality unit procedures. The firm failed to establish scientifically sound specifications and test procedures, leading to inadequate testing for raw materials and finished products. Additionally, the quality unit's responsibilities were not fully followed, resulting in the release of out-of-specification products and a history of inadequate investigations and process validation.