A Commitment to Quality. A Focus on Safety.
Our Rouses Point facility has a fully integrated QA/QC organization with state-of-the-art analytical equipment for the QC area. Regulatory support is available for CMC documentation and interacting with FDA. In addition, the regulatory affairs organization supports promotional and advertising activities. The site is regularly inspected by FDA, New York DEC, OSHA, EPA and the DEA. And, as evidence of this facility’s commitment to quality and excellence, it has not received an FDA-483 in recent history. The facility has also been inspected by various international agencies, including the Irish Medicines Board (IMB), the Medicines Control Agency (MCA) and a Middle East agency, the Gulf Co-Operative Council (GCC).
