Import Detention Remediation and Resolution Services


Food Drug & Cosmetic Act

Section 801 of the Food Drug & Cosmetic Act States:

"If it appears from the examination of such samples or otherwise that..."

  1. such article has been manufactured, processed, or packed under insanitary conditions... or
  2. such article is forbidden or restricted in sale in the country in which it was produced... or
  3. such article is adulterated, misbranded, or in violation of section 505 (New Drugs)

"then such article shall be refused admission..."

The ThinSpring Solution

We can help you remediate and resolve issues regarding the FDA's standard of proof including whether a product

  • Appears to be adulterated or misbranded
  • Appears to be unapproved new drugs
  • Appears to have been manufactured not in accordance with GMPs

We can also help resolve admissibility decisions including

  • Historical Data
  • Examinations
  • Information from other sources
  • Other evidence

We will help you understand what directs the FDA's action

  • The intent of the law is to deny importation of violative articles
  • Articles are expected and required to be in compliance at the time of entry
  • Compare to other sections of FDA law (seizure)
  
 
  Key Features:
 
  •   Help you understand the FDA's standard of proof  
 
  •   Walk you through admissibilty decisions  
 
  •   Understand, remediate and resolve FDA actions  
 

By choosing ThinSpring, you will get an experienced and knowledgeable team to guide you through the complexities surrounding the import detention remediation process, resulting in a satisfactory resulution approved by the FDA.