IMPORT/EXPORT/DOMESTIC

FDA-DETENTION/FDA-DWPE/HACCP/USDA

• LABORATORY EXPERTISE IN CHEMISTRY & MICROBIOLOGY FOR THE FOOD INDUSTRY
  
  
• COMPREHENSIVE UNDERSTANDING OF THE IMPORT PROCESS
  
  
• YOUR PARTNER TO GUIDE YOU THROUGH FDA DETENTION

My product is detained, what does that mean?

It means that the FDA has made an initial determination that the product appears to violate FDA's requirements and is subject to refusal of admission into the United States. You can find published FDA Import Alerts here: http://www.accessdata.fda.gov/ImportAlerts/ora_import_alert_list.html

What can I do if FDA detains my product?

You can introduce evidence to overcome the appearance of a violation, referred to as testimony, by hiring a private laboratory to analyze your product, or in some cases request FDA's permission to take steps to correct a violation, referred to as reconditioning.

Manufacturer's certificates and or expressions of confidence are not adequate substitutes for private laboratory analysis and the FDA will not analyze your product for you.

Testimony - introducing evidence to support the release of your product

What FDA standards should a private lab packet meet?

A complete lab packet includes a sample collection report and other supporting documents reflecting a representative sample from the actual goods offered for import. It is in your best interest to choose and to work with a private lab that has experience with offering analytical testimony to FDA.

Useful links

Guidance for providing analytical results can be found here: http://www.fda.gov/ScienceResearch/FieldScience/default.htm
Regulatory Procedures Manual. You may wish to review Chapter 9, Import Operations for more details to better understand detentions, notices, refusals, the rights of an importer to submit testimony, etc: http://www.fda.gov/ora/compliance_ref/rpm/chapter9/ch9.html
Imports page of the FDA website where you can learn more about the importation process and your rights and responsibilities as an importer: http://www.fda.gov/ora/import/ora_import_program.html

Import Detention Resolution - The Solution

At ABC Research Corporation our devotion to personalized customer service and focused knowledge of the import process have made us the laboratory of choice. We consistently communicate with our customers and the FDA to assure that your product detention time is minimized. In addition, our team can consult with you to identify and put in place the corrective actions required to prevent future detentions.

FDA Testing and Regulatory Compliance

The Food and Drug Administration requires strict adherence to the reporting format of private laboratory packet submittals. ABC Research Corporation has worked with the FDA in the development of our Import Detention Resolution Packet (IDRP) to assure fast review and acceptance of our findings by the FDA. Using an ISO 17025 Accredited Laboratory is important to regulators and is being considered mandatory in current legislation for private laboratory testing of detained product.

FDA Methodologies and Analytical Practices

As part of our ISO 17025 Accreditation we adhere to official methodologies and use industry leading analytical practices. These include AOAC, AOCS, USDA and FDA Bacteriological & Pesticide Analytical Manuals (BAM and PAM).

IDRP Analyses

• Extraneous Material Analysis
• Microbiological Analysis
• Chromatographic Analysis
• Chemistry Analysis

Since 1967 - Accurate reporting, Better-quality systems and a Commitment to service, have earned ABC Research Corporation the honored allegiance of our clients and the admiration of government regulators. Partner with us in our effort to ensure our foods are safe for the world to consume.

Download PDF brochure

For More Information Please Contact:

Dean Leaman - Director of Business Development - Import/Export
Cell: 954.305.2806 • Email: dean.leaman@abcr.com • Miami Office