FDA clearance and FDA compliance are not the same thing.
Entry data tells FDA what is being imported and supplies the information used for screening. It does not certify that the product is legally compliant, and FDA release is not the same as product approval.
What entry transmission does
FDA receives entry information electronically through ACE. FDA uses the submitted data together with its internal systems and risk-screening tools to determine whether the line may proceed, requires documents, should be examined or sampled, or requires further compliance review.
What product compliance covers
Depending on the product, compliance can include labeling, permitted ingredients, facility registration, product listing, premarket authorization, performance standards, prior notice, FSVP, good manufacturing practices and other requirements.
Correctly transmitting an FDA entry cannot cure defective labeling or another underlying compliance problem.