The consequences of not renewing US FDA registration can be significant, depending on the type of facility that operates and the products they manufacture.
Food facilities:
Expired registration: If your registration expires, the FDA will consider it a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This can lead to:
Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.
Seizure of products: The FDA may seize the products if they believe that the products are manufactured in an unregistered facility or pose a public health risk.
Injunctions: The FDA may seek a court order to prevent from continuing to operate your facility until you come into compliance.
Loss of business: Potential customers and suppliers may be hesitant to do business with a facility that is not in good standing with the FDA.
Medical device establishments:
Expired registration: Like food facilities, an expired registration for a medical device establishment is a violation of the FD&C Act and can lead to:
Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.
Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for medical devices manufactured in unregistered establishments.
Import restrictions: The FDA may restrict the import of medical devices manufactured in unregistered establishments.
Drugs
Expired registration: Like other registration, an expired registration for drug establishments is also violation of FDA&C Act and can lead to:
Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.
Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for drugs manufactured in unregistered establishments. They will consider the drug as misbranded and de-activate all the drugs listed FDA.
Import restrictions: The FDA may restrict the import of drugs manufactured in unregistered establishments. Also, they may seize the products if they believe they are manufactured in an unregistered facility or pose a public health risk.
Liberty Management Group, as a renowned FDA consulting firm can help the companies in renewing the food establishment, drug establishment and medical device establishments in a timely manner.
Sudha
Regulatory Consultant
Email: office@libertymanagement.us