Chinese food producers to comply with US FDA routine inspections

As the regulations on food safety in the US become stricter, an increasing number of Chinese food producers that sell products to the US are facing regulation and onsite inspections by the US Food and Drug Administration (FDA). However, unfamiliarity with relevant FDA regulations, cultural differences and numerous other factors regularly place Chinese facilities at a disadvantage when responding to FDA inspections, even leaving them sometimes at risk of being penalized. Therefore, the authors would like to share some key compliance points in the response by food product enterprises to routine inspections conducted by the FDA.

FDA registration and recordal with the domestic inspection and quarantine authorities. The FDA Food Safety Modernization Act (FSMA) revises section 415 of the Federal Food, Drug and Cosmetic Act (FDCA), requiring facilities that manufacture, process, pack or hold foods for consumption in the US to: (1) register with the FDA and update such registration once every two years; and (2) submit additional registration information to the FDA, including warrantying that they will permit the FDA to inspect their facilities at the times, and in the manner, permitted by the FDCA. These registration requirements apply to Chinese food production, processing and packing facilities (export facilities) that sell products to the US.

The FDCA requires export facilities to register with the FDA. However, in practice, as many export facilities have adopted the distribution model to sell their products – i.e., they sell their products to distributors, which then sell the relevant products abroad – numerous FDA registrations are actually carried out by the distributors on the behalf of the export facilities, a fact of which the export facilities are not necessarily aware, or to which they give tacit consent, and their registered contact information may be inconsistent with the actual particulars of the export facility. Accordingly, most export facilities, when they receive an FDA inspection notice, are not aware that they have been registered with the FDA. In an onsite inspection, the FDA officials will inquire about the export facility’s registered particulars, and the facility can admit the above situation truthfully.

Amy Ye is a senior partner and Dora Feng is an associate at AllBright Law Offices. Huang Xuan, a partner at AllBright, also contributed to this article