Preparation and Assistance with FDA regulatory audits

It is becoming more common under the new regulations for food products, for US authorities to conduct inspection audits of foreign manufacturing facilities which process and export food products to the US. These audits are mainly for review of compliance of Food Safety Programs and Good Manufacturing Practices. At ADEM we are capable and experienced to assist companies in the preparation and accompaniment during these audits to secure proper compliance and with the following up activities to prepare and present corrective actions reports.


“FSMA” Preventive Controls Rule & Foreign Supplier Verification Program “FSVP”

Based on the recently adopted law for Food Safety standard and Preventive Controls standards (21CFR117), all food manufacturers who sell their products in the US market must comply with a new set of standards related to Food Safety Programs including Preventive Controls, Hazard Analysis, Critical Control Points in their manufacturing process. In addition, any manufacturer of ingredients to be used for food products made for sale in the U.S. must meet the  requirements  of the FSVP (Foreign Supplier Verification Program) section of this standard. ADEM’s team of experts can assist food manufacturers in their preparation, design and implementation of comprehensive Food Safety programs.  Lack of substantial compliance of this law may represent a denial of entry into the US at the port of entry for any food product.


Nutrition Facts TableFood Product Label and Nutrition Facts Review

All food products to be sold to consumers in the US must comply with the US FDA’s Food Labeling Regulations as they appear in the Federal Food, Drug and Cosmetic Act of the Chapter 21 of the Code of Federal Regulations and in the Fair Packaging and Labeling Act. This applies to products sold in the US market and manufactured by processor in the US and any other nations. ADEM is specialized in reviewing and assessing compliance of most food products’ labeling, particularly in dairy and beverages categories.

Food Product Identity and Classification

Many food products in the US have a designated standard of identity as defined by the US-FDA, this identity determines its formulation, processing and identity. Nonetheless, it is common for ethnic products to be classified outside or the established standards of identity, allowing them to be less regulated, while maintaining it safety and legality. We have extensive experience in successfully and legally classifying food products and beverages for sale in the US market while properly comply with only those regulatory standards the specifically apply to each product.

Food Facility Registration & Agency

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the Food Safety Modernization Act (FSMA) requires that facilities and companies that manufacture, process, pack and store food for consumption in the United States of America register their facilities information with FDA. This registration process must be renewed every other year. It is the responsibility of a registered food facility to secure food safety measures in their establishments to reduce and control the probability of causing serious adverse health consequences to consumers in the US. All facilities’ registrations will require a US agent individual of firm who will be the point of contact between the FDA and the registered company. ADEM is a qualified service firm to advise food manufacturers and processors to identify their qualifications and process their registration with the FDA as well as to serve as their agent.