How To Check The Authenticity Of FDA Certification

- Apr 29, 2020-

How to check the authenticity of the US FDA certification?

    How to check the authenticity of the US FDA certification? Speaking of this issue, I would like to say a few more words and also want to clarify, then it is necessary to explain the type of FDA certification clearly. According to the requirements of the FDA Act, the US Food and Drug Administration (FDA) Issuing a kind of certification, that is GMP Good Manufacturing Practice System certification. So what is GMP certification? The so-called GMP is the abbreviation of English GOOD MANUFACTURING PRACTICE, the Chinese meaning is "Good Manufacturing Practice". The World Health Organization defines GMP as a set of standard regulations that guide the production and quality management of food, drugs, and medical products. GMP is a set of compulsory standards applicable to pharmaceutical, food and other industries. It requires enterprises to meet hygienic quality requirements from raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control in accordance with relevant national regulations to form a set of operational The operation standards help enterprises improve the enterprise's sanitary environment, find problems in the production process in time, and improve them. In brief, GMP requires that pharmaceutical, food and other production enterprises should have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of final products (including food safety and hygiene) meets regulatory requirements.

    If you are inquiring about the GMP system certification issued by the US Food and Drug Administration FDA, you can communicate through the online contact method on the official website of the US FDA, or you can query the FDA staff through e-mail. Just prove your identity. For specific enquiries, please contact FDA staff directly. They will help to check, but the speed will be a bit slow, they reply to the mail very slowly, sometimes no response for half a month. If you find it inconvenient to inquire through the contact information on the FDA official website, you can also inquire through the US FDA representative office in China. There are currently two FDA representative offices in China, in Guangzhou and Shanghai. There is no other way to check.

    In addition to the GMP system certification, the US FDA does not issue any certificates. Whether it is food or medical devices, after passing the FDA certification or FDA registration, only the product registration code or enterprise registration code or 510K is provided to the applicant. Registration code. In addition, no certificates will be issued. I often see a lot of colorful things on the Internet that claim to be FDA certifications. They often mislead consumers, thinking that they are really certifications issued by US FDA agencies. In fact, they are not. Those are all service certificates issued by the agency company and have nothing to do with the US FDA agency. Those are all to give customers a basis. So there is no need to use the FDA certification certificate to query the entrance. The one we encountered the most was inquiries about the FDA certification of food and medical devices, and asked us how to query this certificate. We are also very helpless, because many agency companies on the Internet will provide a certificate to the customer, saying that it is an FDA certification, the customer does not know whether it is true, we are very troubled, because we explained to the customer that the US FDA is Without issuing any product certificate, many customers will not believe it and think we do not understand. But this is indeed the case. In addition to the GMP system certificate, we really have not heard that FDA will issue other certificates.

    As for how to check the authenticity of the FDA certification certificate, because there is no special certificate query entry in the FDA database system, it is impossible to conduct public queries. It can only be assisted by the official staff of the US FDA. They can query within the system. Yes, we outsiders are not allowed to make inquiries. I am talking about the FDA certification, not the registration code for medical devices. Medical device registration codes can be publicly queried. However, the FDA certification certificate cannot be queried, because FDA itself does not issue any product certificate, but only issues a GMP management system certificate.