FDA recently announced a program under which it will undertake voluntary visits of facilities involved in manufacturing and testing tobacco products. The program is intended to give FDA an opportunity to learn more about the manufacturing practices that are unique to the tobacco industry by observing manufacturing operations, from the receipt of raw materials to the distribution of finished products.
FDA notes that this program is educational in nature, and is not intended to replace official FDA inspections. Our Tobacco practice has assisted many clients with the FDA inspection process, including preparation for inspections and procedures manuals. If you are interested in our assistance with these issues, please let us know.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco practice partner, at 804.697.1420 or by email.