(Silver Spring, MD) -- AHPA’s Guidance for Addressing FDA Inspections of Dietary Supplement Facilities is now available for purchase from AHPA’s online bookstore. The Guidance will help companies understand their rights and obligations when the FDA inspects a facility where dietary supplements or ingredients are manufactured, processed, packed, or held. It provides descriptions and analyses of the current federal laws relevant to facility inspections and suggests ways to prepare for and conduct inspections in a manner that fully complies with these laws.
The Guidance is presented in four sections:
Part 1 reviews FDA’s inspection authority, based on the Federal Food, Drug and Cosmetic Act and the Bioterrorism Act.
Part 2 provides suggestions for advance preparation for an FDA inspection.
Part 3 covers what should be expected during an FDA inspection.
Part 4 discusses the observational findings that follow an inspection and maintaining a thorough internal record of each inspection.
The Guidance also includes a “standard operating procedure” (SOP) template that companies can customize to their specific needs to establish a written SOP for FDA inspections. Copies of the current laws that form the primary basis upon which most inspections are conducted are also provided.
This new AHPA Guidance is now available at AHPA’s online bookstore at a cost of $110 for AHPA members, $195 for non-members: http://www.ahpa.org/bookstore.htm.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org