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FDA Detention - Medical Device, Food, Drugs and Cosmetics

Most of the products detained by FDA are due to non-compliance with FDA requirements. Liberty Management Group Ltd. assists exporters and importers to release the detained product by brought the product in to compliance with the FDA regulations.

FDA Detention of Medical Device

The most common reasons FDA detain a medical device are

  • The manufacturer is not registered with FDA
  • The manufacturer doesn't have a US Agent
  • The exporter is not registered with FDA
  • The importer is not registered with FDA
  • The medical device is not listed with FDA
  • The medical device labeling is not complying with FDA regulations
  • The medical device doesn't have 510(K) clearance or PMA

FDA Detention of Food products

The most common reasons FDA detain Food products

  • The food establishment is not registered with FDA
  • The manufacturer doesn't have a US Agent
  • The food exporter is not registered with FDA
  • The food importer is not registered with FDA
  • The prior notice is not issued
  • The food labeling is not complying with FDA regulations
  • The food is adulterated, misbranded or filthy

FDA Detention of OTC Drugs and API's

The most common reasons FDA detain OTC Drugs and API's

  • The drug establishment is not registered with FDA
  • The manufacturer doesn't have a US Agent
  • The drug products are not listed with FDA
  • The drug doesn't follow OTC Monograph
  • OTC drugs / API's doesn't have proper labeling

FDA Detention of Cosmetics

The most common reasons FDA detain Cosmetics

  • The cosmetics contain unsafe colors
  • The cosmetics contain a poisonous or deleterious substance
  • The cosmetic labeling doesn't comply with FDA requirements
LIBERTY MANAGEMENT GROUP LTD.
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Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@fdahelp.us