I. Introduction to FDA Documents
FDA documents are certificates issued by the U.S. Food and Drug Administration to companies to ensure the safety of their biologics, medical devices, food supply, cosmetics, and other products, thus effectively protecting public safety and health. An official document from the FDA agency should be provided when submitting an application.
(1) Basic FDA Documentation Requirements
Only manufacturers are required to register with the FDA. To obtain this document, contact the manufacturer directly
Is a screen shot from the FDA website
Includes the name and address of the manufacturer
Must include the registration number
States that the FDA registration certificate on the screen shot is "valid" or "on sale". "On Sale"
Must apply to the item you are requesting permission to sell
(2) Notes on FDA Documentation
Please be sure to provide a screenshot of the screenshot from the FDA's website
Documentation needs to be clear and complete, so please do not provide a partial screenshot of the application
If you are requesting permission to sell a product, you must include the manufacturer's name and address.
If there have been recent changes to your FDA documents, please provide the latest screenshots
(3) Examples of Errors
Introduction of Good Manufacturing Practice (GMP) Documents
Good Manufacturing Practice (GMP) is a set of guidelines for the pharmaceutical, food, and other industries. A set of mandatory standards applicable to pharmaceutical, food and other industries, requiring pharmaceutical, food and other manufacturers should have good production equipment, rational production process, perfect quality management and strict testing system to ensure that the final product quality (including food safety and hygiene) in line with the regulatory requirements. Please choose a testing organization with the qualification of testing GMP for testing.
(1) Basic requirements for GMP documents
Contains registration number, certification date and its validity
Expiry date cannot be a date in the past
Must contain the manufacturer's name and address
Must be issued by a third-party inspection service
Must contain a reference to the appropriate U.S. or international standard
(2) Example of a GMP document