All facilities which manufacture, process, pack or hold food must register with the FDA.  A commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods (AF) or low-acid canned Foods (LACF) shall register and file with FDA information including the name of the establishment, principal place of business, the location of each establishment in which that processing is carried on, the processing method, and a list of foods so processed in each establishment (21 CFR 108.25(c)(1) and 21 CFR 108.35(c)(1)). A commercial processor engaged in the processing of AF shall provide FDA with information, using Form FDA 2541e, on the scheduled processes for each acidified food in each container size (21 CFR 108.25(c)(2)). An analogous requirement for process filing, using either Form FDA 2541d, 2541f or Form FDA 2541g, applies to a commercial processor that manufactures, processes, or packs LACF (21 CFR 108.35(c)(2)).

Types of Facilities Required to Register:

  • Food facility registration for facilities with fewer than 500 employees and an annual revenue greater than $1,000,000.
  • Qualified facility registration for facilities with an annual revenue of less than $1,000,000.