An Italian pharmaceutical firm, Corden Pharma Latina S.p.A, Italy, was inspected from May 21-29, 2015. As a result of this audit the FDA issued a Warning Letter on May 20, 2016. The Warning Letter summarized cGMP violations for finished pharmaceuticals, 21 CFR parts 210 and 211 as well as significant deviations from cGMP for active pharmaceutical ingredients (API). Because the … [Read more...]