Get Your Products Released From FDA Import Detention

With more former FDA employees than any other company, we can help get your products released from FDA detention fast. Get your questions answered here.

We Can Help Get Your Products Released From FDA Import Detention

Maybe you’ve navigated the FDA import process several times. Maybe this is your first shipment. But FDA has detained your products because they appear to be…

    • Adulterated or contaminated
    • Misbranded
    • Forbidden or restricted for sale

Whatever the case, detained shipments waste time, harm your reputation and cost money each day your products are sitting in a warehouse rather than out in commerce. It’s important to act quickly and partner with a laboratory and consultants who can help get your products released from FDA detention as soon as possible.

I Received an FDA Notice of Action. Now What?

Companies often discover that FDA detained their shipment through an FDA Notice of Action (NOA). It will include information you need to attempt to get your products released, including…

[

How the shipment appears to be in violation

[

Notification of your right to hire a third-party lab to provide evidence that your products are not violative

[

The number of days you have to provide testimony to the FDA (typically 20 calendar days)

[

The contact information for the Consumer Safety Officer (CSO) with whom you should work to resolve the issue

Respond to a Notice of Action Immediately

If you receive a Notice of Action, read it immediately. Understand the “charges”, which are the reasons the shipment is detained. Find the “respond by” date so you can make a plan.

FDA allows you to provide evidence to overcome the charges or request to recondition the product to resolve the issue.

FDA Import – We Can Help Get Your Products Released Quickly

The FDA import process can quickly become confusing and even intimidating. The submission of evidence to FDA must contain certain information, otherwise it can be rejected. If that happens, you may have to export or destroy the products, wasting time and money.

Contact us today so we can help ensure that doesn’t happen.

Why Partner With Certified Laboratories (A Certified Group Company)?

N

More than 40 years of experience in FDA detention testing

N

More former FDA employees than any other company

N

Testing done using FDA-accepted methodology

N

Ability to expedite the release of detained products

N

Nationwide sampling – we can help you no matter what port you use

N

Experience working with importers and overseas processors to overcome FDA detentions through the 766 process (reconditioning)

Our FDA Lab Report Helps Get Your Products Released From FDA Detention

Lab reports submitted to free your products from FDA detention can be up to 400 pages. It takes experience and attention to detail to ensure all required forms and information are accurately completed and included. Otherwise, FDA can reject the report, potentially causing you to lose the shipment.

Thanks to our experience and proven processes, we ensure your report contains everything FDA requires, as explained below:

Sample Collection

The appropriate and representative sampling of a product is crucial to accurate analysis. We document the sampling-collection process with the following data:

    $

    Date of Collection

    $

    Identity of the sampler

    $

    Size & description of lot

    $

    Size & method of collection

    $

    Chain of custody

    $

    Sampling pictures

    $

    Sampling plan followed

    Analytical Packages

    All reports we submit to FDA contain the following:

    $

    Documentation associated with the sampling process, which must be on file with FDA

    $

    Sampling photo reports

    $

    Properly signed & dated worksheets that include:

    • Calculations & results
    • Methods used and any modifications, instrumentation, calibrations & conditions
    • Sample preparations & any modifications
    • Any other necessary information
    $

    Source, preparation & purity of standards

    $

    All chromatograms or spectra

    Other Requirements

    To aid the Food and Drug Administration in evaluating the quality of our work and to help them in assuring the accuracy, validity and reliability of our results, we provide or make available the following:

    $

    A list of equipment used for conducting the analysis

    $

    A list of each type of analysis and imported commodity handled by the laboratory

    $

    Appropriate laboratory information bulletins LIB's

    $

    Curricula vitae of personnel

    $

    Updated and accurate quality control records

    $

    Updated compendia of the latest official methodologies (AOAC, BAM, etc.)

    Our Testing Capabilities Exceed the Competition

    When it comes to FDA import testing and detention without physical examination (DWPE) work, we strive to be the best in the fields of microbiology, analytical chemistry (using state-of-the-art LC/MS-MS systems to detect nitrofurans, pesticides and other approved chemo-therapeutic agents), sanitation analyses and decomposition (organoleptic) consultation. We offer a full range of tests, including those listed below.

    Chemistry analysis, including…

    $

    Antibiotic Residues

    $

    Fluoroquinolones

    $

    Gentian Violet

    $

    Malachite Green

    $

    Nitrofurans

    $

    Artificial Color

    $

    Borates

    $

    Histamines

    $

    Optimized Monier-Williams Sulfite

    $

    Saccharin, Cyclamates & Dulcin

    Microbiological analysis, which includes…

    $

    Coliform Count

    $

    E. coli

    $

    Enteropathogenic E. coli

    $

    Listeria Monocytogenes

    $

    Salmonella

    $

    Staphylococcus

    $

    Salmonella

    $

    Vibrio p-Haemolyticus

    $

    Total Plate Count

    $

    Vibrio Cholerae

    Organoleptic examination for decomposition of…

    $

    Canned Crabmeat

    $

    Canned Tuna

    $

    Fresh Fin Fish

    $

    Frog Legs

    $

    Frozen Fin Fish

    $

    Lobster

    $

    Octopus

    $

    Scallops

    $

    Shrimp

    $

    Squid

    Chromatographic analysis using TLC, GC & HPLC, including…

    $

    Color

    $

    Coumarin

    $

    Pesticides

    $

    Indole

    Extraneous material analysis, including…

    $

    Feather Barbules

    $

    Fragment Counting

    $

    Hair Identification

    $

    Insect Identification

    We Operate ISO-Accredited Labs for Maximum Quality & Accuracy

    Our Analytical Capabilities

    A laboratory must practice current analytical and FDA methodologies to maintain its acceptance. Certified Group maintains an extensive library that includes Official Methods of the AOAC, USP, BP, AACC and AOCS; and FDA Bacteriological and Pesticide Analytical Manuals (BAM and PAM). In addition, our library of material includes…

      • Laboratory Information Bulletins (LIBs)
      • Macroanalytical Procedures Manual
      • Current journals, including JAOAC, Journal of Agriculture and Food, Journal of Food Science
      • Import Alerts
      • Inspection Operations Manual
      • Compliance Policy Guide

    Need help with an FDA import?

    Contact us right away by completing the form below.

    Sampling of your product can sometimes be a problem, Certified Laboratories is familiar with all FDA sampling schedules. We have a staff of trained samplers who can handle the complete sampling procedure or, if you prefer to submit the sample yourself, we will explain to your personnel the proper sampling plans to employ. We are always prepared to take responsibility for sampling at the following ports:

     

    BOSTON • NEW YORK / NEW JERSEY • CHICAGO • SEATTLE • PHILADELPHIA • LOS ANGELES • SAN FRANCISCO • TAMPA • HOUSTON • LAREDO • EAGLE PASS • EL PASO • NOGALES • SAVANNAH • MIAMI • OTHERS BY REQUEST