FDA Detention Testing Lab

Partner with Eurofins Today to Support Your FDA Detention Needs

Expanding your business by importing human food and animal products is complex and becomes more demanding when the Food & Drug Administration (FDA) detains the product(s) upon entry. The FDA regulates the importation of food, drug, and consumer care products into the United States utilizing a risk-based approach and creating Import Alerts. These import alerts are based on known and potential violations related to the product composition, manufacturing conditions, product origin, and more. Import Alerts dictate and allow for Detention Without Physical Examination (DWPE) by the FDA.

You need to act fast when your product is detained. Choose a partner with the expertise and agility to support your response to the FDA and get your product released as quickly as possible.

6 EASY STEPS TO ADDRESS/COMBAT IF YOUR PRODUCT IS DETAINED

You received a Notice of Action from the FDA. Now what?

1. Contact Eurofins

Submit your information here to quickly connect with a member of our dedicated FDA Detention service team.

2. Provide the Related Paperwork

Eurofins will request you share paperwork that will be used to provide you a quote and as part of the final package submission to the FDA.

3. Project Quotation and Timeline Establishment

Eurofins will provide a detailed quote including a project Turn Around Time (TAT), and possible expedited options if requested and available. With an accepted quote and timeline, you can request an extension to the Notice response date if necessary.

4. Prepare for Sampling

Representative third-party sampling conducted by Eurofins’ network of professional samplers helps ensure the analytical work is accurate and properly documented for the submission of the FDA detention package. Our professional samplers follow sample collection procedures detailed under the FDA Investigations Operation Manual requirements.

5. Laboratory Analysis

Upon receipt of the collected samples and completion of the chain of custody, the laboratory begins testing the product for the analyte(s) of concern. Eurofins LAAF-accredited laboratories follow strict testing protocols and comprehensive documentation practices to meet FDA requirements and agency expectations.

6. Package Submission

When testing is complete, Eurofins compiles a comprehensive document packet and submits through FDA’s Import Trade Auxiliary Communications System (ITACS).

WHY CHOOSE EUROFINS?

FDA Detention Expertise

Our laboratories are accredited to the FDA’s LAAF Program, have submitted thousands of packets through ITACS, and continue investing in new technologies. Eurofins works closely with the FDA and has established an efficient and consistent reporting format for FDA agency acceptance.

Nationwide Sampling Coverage and Large Test Portfolio

Our portside locations and matchless nationwide sampling network ensure you’re supported wherever your product is located. With over 150 analytes within our FDA-approved scope we support the most common Import Alerts and continue investing in expanding our scope based on emerging trends and hazards.

Full-Service Detention Partner

When you select Eurofins as your partner, we seamlessly manage the sample collection, chain of custody, testing, and package submission through ITACS. We can support you in obtaining an extension and facilitate discussion with your FDA-assigned officer and agency.

TYPE OF TESTS PERFORMED

Acrylamide
Amino acids
Antioxidants
Artificial colors
Drugs not approved in food or dietary supplements including PDE5 inhibitors (sidenafil, vardenafil, tadalafil, avanafil, for example)
Escherichia coli (coli)
Herbicides
Histamines
Listeria
Melamine and cyanuric acid
Metals and elements such as arsenic (speciation), cadmium, mercury, lead, tin, antimony, nickel, chromium, manganese, iron, copper, zinc, selenium, molybdenum, iodine, etc.
Mycotoxins (aflatoxins, ochratoxin, patulin, and fumonisin)
Nutrition label and claim support (fat, protein, carbohydrates, calories, sugars, sugar alcohols, cholesterol, vitamins, and minerals)
Pesticides
PFAS
Preservatives
Residual solvents
Salmonella
Staphylococcus aureus
Total Aerobic Microbial Count
Veterinary drug residues
Yeast and mold