Do not be misled into thinking that by meeting the Food Safety Modernisation Act (FSMA) Part 117 (Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Control for Human foods) that your facility automatically meets the USFDA regulatory requirements. It must be noted that a USFDA inspection of your facility can be much wider in scope than just Part 117.

European food and drinks exporters to USA, who export for the first time, can feel overwhelmed by the scope of US Codes of Federal Regulations.

A single inspection may focus on multiple requirements, such as a canned tuna product that may be inspected for compliance with seafood hazard analysis and critical control point (HACCP) systems, Part 113 low acid canning regulations and Part 11 electronic records and electronic signatures, labelling requirements and current GMPs.

FSMA Part 117 rules also makes exemptions for certain alcoholic drink manufacturers who are regulated by Tobacco and Alcohol Tax Bureau and subject to the Federal Alcohol Administration Act and the Internal Revenue Code.

US FDA is prioritizing facilities that manufacture high risk food commodities including but are not limited to: modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; dairy products including soft, semi-soft, soft ripened cheese and cheese products; unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; spices; shell eggs; sandwiches; prepared salads; infant formula; and medical foods. FDA may conduct routine inspections of other food commodities as part of its surveillance activities.

The purpose of an FDA inspection of a food facility is to determine a facility’s compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations of Title 21 of the U.S. Code of Federal Regulations (CFR). Please note that these are inspections of individual facilities are designed to evaluate a facility’s adherence with applicable U.S. laws.

Global Quality Consultants can give clarity to the CFRs for Human Foods and provide training and support to your business inspection readiness journey.