Does FSMA apply in Puerto Rico?

Yes. Under the Federal Food, Drug, and Cosmetic Act, Puerto Rico counts as a state, so FSMA rules apply to plants on the island just as they do in Florida or Texas.

The Act defines "State" as any State or Territory of the United States, the District of Columbia and the Commonwealth of Puerto Rico (21 U.S.C. 321(a)(1)). The FDA registration rule calls any plant located in a State, Territory, the District of Columbia or Puerto Rico that manufactures, processes, packs or holds food for consumption in the United States a "domestic facility." The Preventive Controls rule (21 CFR 117) applies to domestic and foreign facilities that must register with the FDA. In practice, a Puerto Rico plant needs the same things as a mainland plant: FDA registration, current good manufacturing practices and, unless exempt, a food safety plan prepared by a PCQI.