Certificate of FDA Registration
After completing US FDA Registration, business owners are always looking for a certificate of FDA registration as proof of FDA registration, but FDA is not issuing a registration Certificate. Also, the food facility registrations are confidential, so your customers cannot verify them on the FDA website.
LMG issue a certificate of FDA registration to our customers; you can use this certificate as proof of FDA registration to the industry.
FDA Registration Certificate - Food
FDA Registration Certificate - Device
FDA Registration Certificate - Drug
FDA Registration Certificate - Cosmetic
Amazon FDA Registration certificate
Business owners trying to sell on Amazon are often asked for a Certificate of FDA registration. As per amazon seller support, the below are their requirements (it may change, so please contact amazon for updated requirements).
Option #1 Proof of FDA registration
Earlier, Amazon was asking for an FDA Certificate, but now Amazon is looking for Proof of FDA registration. You can provide the screenshot of your FDA registration with the registration number and valid status proof of FDA registration.
Option #2 Certificate of Analysis (COA)
Only the manufacturer can issue a COA; this document states that the product complies with regulations and meets or exceeds the specification.
Option #3 GMP Certificate
GMP Third-party certification bodies issue GMP (Good Manufacturing Practice) certificates; you need to contact a certification body/registrar for this certificate. The cost of a certificate varies with certification bodies.
Option #4 510(K) Premarket Notification
A 510(K) Premarket Notification is only for medical devices; if you are a medical device manufacturer and your device classification is 510k, you can submit a 510k notification to FDA; it may take 3-6 months to complete a 510k review.