Experience the US Food and Drug Administration FDA inspectors on food factory inspection experience sharing 2

"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.

The relationship between safety and manufacturing process

FDA inspectors attach great importance to the production process and product safety of products, especially those with traditional Chinese characteristics, because the processes of these products are not familiar to them.

First of all, the FDA inspector is concerned with how to prove the food safety of this product and whether there is sufficient evidence to prove that the various quality parameters of the product can ensure the food safety. Second, whether the production process of this product can guarantee this A product safety is formed and stable.

Of course, FDA inspectors spend much more time observing the production site for the most important safety controls throughout the product, with a full understanding of the implementation details of each specific measure.

Our feeling is that FDA inspectors do not overly entangle a process / step with a CCP, but instead focus on the effective prevention / control of various hazards in the process / step.

To point with the surface, the depth of excavation

Site health control, of course, is the focus of on-site inspection. FDA inspectors not only pay attention to the on-site sanitation operation in the production process, but also pay attention to how the after-hours health care of enterprises is carried out in a specific way and observe the implementation of after-school health practices in production sections with large health risks on the spot. .

Our feeling is: once the on-site inspection found that a section of the cleaning is difficult or difficult to protect health, then in the follow-up examination, will focus on their health after class.