1. Introduction to FDA documents
FDA documents are issued by the U.S. Food and Drug Administration to enterprises to ensure the safety of their biological products, medical devices, food supplies, cosmetics and other products. , thereby effectively protecting public safety and health certificates. Official documentation from the FDA agency should be provided when submitting the application.
(1) Basic requirements for FDA documents
Only manufacturers need to register with FDA. To obtain this document, please contact the manufacturer directly
Is a screenshot from the FDA website
Include the manufacturer's name and address
Must include the registration number
State that the FDA registration certificate on the screenshot is "valid" or "on sale"
Must apply to the goods you request permission to sell
(2) Submit to FDA Notes on documents
You must provide a screenshot of the FDA website
The content of the document must be clear and complete. Please do not provide only a partial screenshot when applying
If your FDA document has had information changes recently, please provide the latest screenshot
(3) Error examples
2. Introduction to Good Manufacturing Practice (GMP) documents
Good Manufacturing Practice (GMP) is a set of mandatory standards applicable to pharmaceutical, food and other industries. It requires pharmaceutical and food production companies to have good production equipment, reasonable production processes, perfect quality management and strict Testing system to ensure that final product quality (including food safety and hygiene) meets regulatory requirements. Please choose a testing agency with GMP testing qualifications for testing.
(1) Basic requirements for GMP documents
Include registration number, certification date and its validity
The validity period cannot be in the past
Must contain manufacturer’s name and address
Must be issued by a third-party inspection service
Must contain corresponding U.S. or international standard reference
(2) GMP document Example