Valeant Pharmaceuticals International received a Form 483 citing problems in its organizational structure, design validation procedures, and other issues.
The FDA visited the company’s Rochester, N.Y., facility in late August and early September 2016 and found the facility was not organized to ensure that devices were produced according to regulatory requirements.
Specifically, responsibility for work performed under the quality management system did not assure that necessary activities occurred prior to approval. Notably, acquired products that needed to be integrated into the QMS were not fully integrated into the design management system. Moreover, products reviewed under the nonconforming product system were not properly evaluated.