FDA 483 - Fareva Amboise - May 25, 2018

Fareva Amboise, a drug manufacturer in Poce Sur Cisse, France, received a Form 483 for significant quality control and production deficiencies. The inspection revealed issues including inadequate vendor qualification, missing material specifications, unvalidated processes, and insufficient controls over computer systems and facility operations. These observations collectively indicate a lack of assurance regarding drug product identity, strength, quality, and purity.