What is the FDA?

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States.

 


FDA Form 482
 
A written, signed Notice of Inspection issued to a firm by an FDA Investigator who has the authority to enter and inspect a firm operating at a business location.



FDA Form 483
 
A listing of observations of objectionable conditions and practices, pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, to assist firms in complying with the Acts and regulations enforced by the Food and Drug Administration. This listing is presented to the highest management official available upon completing an inspection and before leaving the premises.