Detailed explanation of FDA factory inspection process

The FDA (Food and Drug Administration) is under the jurisdiction of the US Department of Health and Human Services (DHHS) and is responsible for the management of drugs, food, biologics, cosmetics, veterinary drugs, medical devices, and diagnostic supplies nationwide. FDA factory inspections are an important means of ensuring the safety and effectiveness of these products. Through rigorous review and testing, they ensure that products meet strict safety standards before entering the market, thereby effectively protecting consumer health. The following is a detailed explanation of the FDA factory inspection process.

1、 Determine product classification and category

The first step in the FDA certification process is to determine the classification and category of the product. Different categories of products need to meet different standards and regulations, so it is crucial to correctly determine the product category. The FDA mainly classifies products into three categories: drugs, medical devices, and food/cosmetics.

Drugs: including prescription drugs, over-the-counter (OTC) drugs, and biologics. The factory inspection of drugs is based on the 21 CFR chapter on drug regulations.

Medical equipment: including various medical devices, instruments, tools, implants, in vitro diagnostic reagents, etc. The factory inspection basis for medical devices is QSR820 regulation, also known as 21CFR820 (recently updated as QMSR).

Food/Cosmetics: Food factory inspection is based on the US GMP110 regulation 21CFR Part 110, while cosmetics factory inspection is based on the relevant cosmetics regulations of the FDA.




2、 Develop plans and schedules




Once the category and classification of the product are determined, a detailed plan and schedule need to be developed next. The plan should include laboratory testing, demonstration, manufacturing, production approval, and other aspects. The purpose of developing this plan and schedule is to ensure the smooth progress of the entire certification process, while ensuring that all testing and demonstration materials comply with FDA standards and regulations.




Laboratory testing: Determine the chemical, physical, and biological tests required based on the product type.

Demo: Prepare a functional demonstration of the product, including usage methods, effect demonstrations, etc.

Manufacturing: Develop detailed production processes and quality control plans.

Production approval: Ensure that all production processes comply with FDA requirements and prepare production approval certificates.




3、 Prepare and submit the application




Preparing and submitting the application is the most important step in the FDA certification process. The application should include all necessary information and materials to demonstrate that the product does indeed comply with FDA standards and requirements. The application materials required by the FDA typically include but are not limited to: product specifications, ingredient lists, manufacturing processes, quality control plans, laboratory test results, product demonstration videos or images, and any relevant safety assessment reports.




When preparing application materials, it is important to ensure the accuracy and completeness of all information, as any omissions or errors may result in the application being returned or delayed in approval. In addition, special attention should be paid to the application format and submission method to ensure that they comply with the latest FDA regulations.




After submitting the application, the FDA will review the application materials. This process may take some time, depending on the complexity of the product and the current workload of the FDA. During the waiting period for the review results, it is recommended that companies maintain smooth communication channels with the FDA in order to timely understand the application status or answer possible questions.




If the application is approved, the FDA will issue the corresponding certification certificate, allowing the product to be sold in the US market. However, this does not mean that companies can relax their vigilance. The FDA also conducts regular sampling tests on products on the market to ensure their continued compliance with safety standards. Therefore, enterprises need to establish an effective quality management system to ensure product quality and safety.