Summary

Description

Specialized Capabilities FCC provides specialized forensic analysis of samples that fall within FDA jurisdiction. These activities include product tampering, counterfeiting of pharmaceuticals, detection of contaminants in foods and pharmaceuticals, economic fraud related to foods and pharmaceuticals and illegal drugs. FCC scientists perform original research to develop methodology to identify poisons and other hazardous materials in pharmaceutical and food matrices. They conduct research to investigate the physical and chemical characteristics and effects of poisons on products regulated by the Agency, and investigate the effects of the product’s matrix on the stability and toxicity of purposely added poisons. The FCC has developed unique capabilities, including complete chemical fingerprinting of poisons, glass, pharmaceuticals, food products and product packaging materials. The Center also has established databases in many areas, such as bulk pharmaceutical ingredients, illegal drugs, product packaging materials, and poisons. FCC scientists have taught many ORA training courses, including Elemental Analysis, Forensics, Update Training for Supervisors, Modern Analytical Methods, Laboratory Procedures and Techniques for Chemists, Advanced Chromatography, Regulatory Science, and New Hire Courses. FCC has provided specialized training in forensics to ORA chemists and to international scientists. The FCC staff interacts with regulatory scientists regarding improvements in methodology and regularly communicates with field and OCI investigators to learn how FCC can best support their activities. Notable methods development: Deepwater Horizon Melamine