In general, a foreign or domestic facility that manufactures, processes, packs, or holds food for consumption in the United States and has to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act (see 21 CFR Part 1, subpart H) is subject to the requirements related to preventive controls (primarily located in subparts C and G) of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 Fed. Reg. 55908) (CGMP & PC rule), unless subject to an exemption. Note that an establishment may also be subject to the Current Good Manufacturing Practice (CGMP) requirements in subpart B; those requirements are not dependent on whether a facility is required to register. Also, the CGMP requirements may apply to facilities or food exempt from preventive controls (see 21 CFR 117.5(k) for exemptions from CGMPs).
