Manufacturing / processing establishment or facilities (domestic or foreign) of Medical device, Drug, Food, blood and biologic products and radiation emitting products require FDA Registration. if the intended purpose of your plastic product is a medical or blood and biologic then you may require FDA registration, please check FDA classification at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
FDA registration number is a mandatory requirements for food facilities who manufacturer or market their products in the USA. after successfully completing food facility registration with FDA, FDA will assign an eleven digit number, this is known as FDA registration number. only for food facility FDA assign 11 digit registration number immediately. other registrations like drug and medical device FDA will assign FEI Number later.
FEI stands for FDA Establishment Identifier or FDA Establishment Identification number. this is a unique number FDA assign for each establishment or facility location. FDA assign this number before site inspection, FDA use FEI number to track the inspections.
fda food facility renewal is in every 2 years. all food facilities must renew their registration between October 1st and December 31st of every even numbered year. if not renewed, FDA will cancel the registration and you cannot reinstate a cancelled FDA registration.
we are a chocolate candy manufacturer from Germany planning to launch our products to the US Market. May i know the US FDA requirements for a chocolate candy ?
there is no FDA approved use for Kratom. also kratom is in FDA detention list, so FDA will detain the product at the port. FDA may consider kratom as a new dietary ingredient. So FDA registration is not recommended for this product.
who need FDA registration ? i am a manufacturer of plastic products do i need FDA registration ?
Manufacturing / processing establishment or facilities (domestic or foreign) of Medical device, Drug, Food, blood and biologic products and radiation emitting products require FDA Registration. if the intended purpose of your plastic product is a medical or blood and biologic then you may require FDA registration, please check FDA classification at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
how can i get FDA Certification for a food product ?
Dear Juan,
Food products require US FDA Registration, not FDA certification, also FDA Registration or FDA registration number does not denote FDA certification.
what is fda registration number ? is this only for food facility ?
FDA registration number is a mandatory requirements for food facilities who manufacturer or market their products in the USA. after successfully completing food facility registration with FDA, FDA will assign an eleven digit number, this is known as FDA registration number. only for food facility FDA assign 11 digit registration number immediately. other registrations like drug and medical device FDA will assign FEI Number later.
what is an FEI number ? is this same as owner/operator number ? how can i get FDA FEI number ?
FEI stands for FDA Establishment Identifier or FDA Establishment Identification number. this is a unique number FDA assign for each establishment or facility location. FDA assign this number before site inspection, FDA use FEI number to track the inspections.
what is the renewal date for FDA food facility registration ? do i need to renew every year ?
fda food facility renewal is in every 2 years. all food facilities must renew their registration between October 1st and December 31st of every even numbered year. if not renewed, FDA will cancel the registration and you cannot reinstate a cancelled FDA registration.
we are a chocolate candy manufacturer from Germany planning to launch our products to the US Market. May i know the US FDA requirements for a chocolate candy ?
Chocolate and Chocolate products comes under US FDA Food regulations. The FDA requirements for the manufacturer are
1. US FDA registration
2. label compliance
3. prior notice
4. GMP compliance
can register Kratom with FDA as a dietary supplement ?
there is no FDA approved use for Kratom. also kratom is in FDA detention list, so FDA will detain the product at the port. FDA may consider kratom as a new dietary ingredient. So FDA registration is not recommended for this product.