FDA EIR - Draco Natural Products, Inc. - March 18, 2019

An FDA inspection of Draco Natural Products, Inc., located in San Jose, CA, was conducted on March 18, 2019. This was the initial Foreign Supplier Verification Programs (FSVP) inspection for the human food importer, carried out under the fiscal year 2019 Center for Food Safety and Nutrition (CFSAN) assignment. The inspection focused on the firm's FSVP records for imported Green Tea from Shanghai Tianyuan Plant Products Co. Ltd., China. Potential hazards associated with such food include biological (e.g., Salmonella), chemical (e.g., pesticides), and physical contaminants. The regulatory framework for this inspection was the FSVP standard requirements, which mandate importers verify that their foreign suppliers produce food in a manner that provides the same level of public health protection as required of domestic food producers. During the inspection, it was observed that Draco Natural Products, Inc. had a comprehensive and compliant FSVP in place for the reviewed product. Their program included a written hazard analysis, documented foreign supplier evaluations and approvals, and appropriate verification activities, such as periodic sampling and testing, and review of supplier's food safety records. Crucially, no violations or objectionable conditions were identified, and therefore, no FDA Form 483a (FSVP Observations) was issued. As a result, no specific required actions were mandated by the FDA. The discussion with management centered on reinforcing the FSVP regulations and providing guidance, including considering the FDA Hazard Analysis and Risk-Based Preventive Controls for Human Food guidance. The firm's FSVP program was deemed to meet regulatory requirements.