FDA Establishment Registration

Fuerst Ittleman David & Joseph, PL represents a wide array of FDA-regulated business, including those engaged in the manufacture, distribution, import and export of foods, drugs, biological products, medicines, cosmetics, anti-aging products and a host of others. In an effort to maintain oversight over the various industries it regulates, FDA requires nearly all companies engaged in the manufacture, storage, distribution, packaging, and labeling, re-packaging or re-labeling to register with the agency in an FDA approved format.

Without proper registration, FDA-regulated companies risk FDA enforcement action, recalls, and potential state-level enforcement actions. Most companies are required to update their registration every year, and the failure to do so can result in added costs and inconveniences to the companies.

FIDJ has years of experience assisting all types of FDA-regulated businesses maintain compliance with FDA regulations, including firm registration. We likewise assist clients in understanding how they must register with the FDA, and in many cases, we can complete the FDA registration on our clients’ behalf.

If you are an FDA-regulated business in need of registering with FDA, contact us today for a free consultation.