Europlaz Technologies Ltd, based in Southminster Essex, is pleased to announce we are now FDA registered as a manufacturer, re-packager and relabeller.
FDA registered organisation
FDA establishment registration is a requirement for any company manufacturing devices intended for use in the United States. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to be FDA registered.
Regulatory agencies like the U.S. Food and Drug Administration (FDA) used to focus primarily on domestic GMP compliance and enforcement. But the number of FDA inspections abroad has grown as importers increasingly source products abroad.
What is the FDA?
From the FDA website:
The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts.
FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations.
Those inspected include:
vaccine and drug manufacturers
food processing facilities
animal feed processors
FDA also inspects:
facilities that conduct studies in people (clinical trials)
laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product
foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States
imported regulated products at the border
FDA conducts several types of inspections to help protect consumers from unsafe products:
pre-approval inspection after a company submits an application to FDA to market a new product
routine inspection of a regulated facility
“for-cause” inspection to investigate a specific problem that has come to FDA’s attention