Experience the US Food and Drug Administration FDA inspectors on food factory inspection experience sharing 1

With the gradual deepening implementation of the U.S. Food Safety Modernization Act (FSMA) and its supporting laws and regulations, the United States FDA has stepped up inspections of overseas export-oriented U.S. food companies to increase food safety for the United States. Global exports to the US food companies from the United States FDA site inspection frequency is higher and higher.

117 Regulation (ie 21 CFR Part 117 Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for human food, Chinese: Good Practices for Human Food, Hazard Analysis and Risk-Based Preventive Control Legislation, otherwise known as: Food Preventive Control Regulations, Acronym: US 117) As one of the core supporting regulations of the US Food Safety Modernization Act FSMA, it is applicable to all manufacturing processes regulated by the FDA and selling food products in the United States (including food products imported into the United States and domestically produced in the United States) , Processing, packaging and storage business. It integrates the requirements of good practices, hazard analysis and prevention and control measures, significantly improving the baseline safety and hygiene requirements of food manufacturers.

On-site inspection notice short notice

For those companies that have been included in the annual inspection program, the FDA generally notifies the business twice. The first time, inform the enterprise will accept the on-site inspection, and asked the company's production season characteristics, as well as traffic matters. The second, to inform the enterprise specific on-site inspection time, and the information to be prepared to do a certain description.

Food 580 this experience of inspection point of view, from the first notification to the second notification of less than one month, from the second notification time to the specific on-site inspection time, also 10 days.

"Company and product introduction" is very important

FDA inspectors into the factory, will hold a meeting with the company management, companies prepare a PPT to introduce the basic situation of the company. FDA inspectors will focus on some of the information they are concerned about, such as:

The output of an enterprise does not simply mean the output of a company that exports to the United States, but the total output.

The type of product exported to the United States, the number of products and customer distribution.

Recent U.S. product exports, and recent production.

Our feeling is: After the FDA has a preliminary understanding of the basic situation of the enterprise, it will focus on the focus of the inspection.

117 Regulations are of concern

FDA inspectors are very concerned about how to implement 117 regulations in the production control of non-exempt products, and have spent some time on understanding the specific aspects of the enterprise in the aspects of "Supply Chain Prevention and Control Measures" and "Allergen Prevention and Control Measures" Implementation of the specific allergens which raw and supplementary materials with the enterprises discussed, and asked the establishment of the corresponding products should be the food safety plan.