For most of the products produced for export to the United States, there is actually no FDA certification, even after passing the FDA factory inspection audit, or FDA audit through the 510(k), the U.S. FDA will state that this is not an FDA certification or accreditation. However, the FDA's audit for its jurisdiction over the product can enter the U.S. market and whether it can continue to enter the U.S. market, often play a decisive role.
The FDA refers to the U.S. Food and Drug Administration, and the products under its jurisdiction are food, food contact materials, drugs, drug ingredients, cosmetics, medical devices, laser products, and tobacco products. Depending on the type of product, the FDA has different ways of regulating it. The FDA audits that you mentioned have different meanings for different products and companies because the FDA may be auditing the product or auditing the factory.
For medical devices with the highest risk level (Class III), generic drugs or new drugs, new dietary supplement ingredients, some recognized safe substances, some food contact materials, etc., can only be marketed in the U.S. after obtaining FDA's review and approval, i.e., for these products, obtaining the approval is one of the knocking bricks; if the approval has not been obtained, then the entry into the U.S. is The FDA will also take action to regulate products that do not enter the U.S. legally, including refusing entry of goods, adding companies to the blacklist, sending warning letters, etc., and publishing the companies on the official website.
In addition, the FDA focuses on post-market supervision, if the enterprise has completed the formal registration, these types of products mentioned above have also been approved, then after entering the United States, there is also the probability of being drawn to the factory audit. Drugs are audited factory probability compared to other types of products factory high, but the U.S. FDA default enterprise in the FDA registration has been in line with the FDA's GMP or cGMP requirements, whether it is drugs, food or the vast majority of medical devices. Therefore, if the enterprise receives the notice of FDA audit factory, not respond or refuse FDA's factory inspection, FDA has the right to take the enterprise goods to increase the strength of sampling, refusing to enter the country or even the enterprise will be added to the blacklist and other actions; if the enterprise after the FDA's factory inspection and audit, there is a serious failure to comply with the requirements of the GMP or cGMP non-conformity, then FDA has the right to take action on these enterprises to add to the blacklist, issue warnings, and so on. If the enterprise after FDA factory inspection audit has serious non-compliance with GMP or cGMP requirements, then the FDA is entitled to these enterprises to take actions such as adding to the blacklist, issuing warning letters, refusing the entry of goods. Therefore, through the FDA factory audit is another basic and critical requirement for products to enter the United States.