FDA Import Detention Sampling & Testing
With over 40 years of experience and more former FDA employees than any other company, we are your trusted partner in navigating FDA Detention Without Physical Examination (DWPE) challenges. Our FDA-accepted sampling and testing methods, combined with nationwide coverage, ensure fast, accurate results to expedite the release of your detained products. Whether you need support with reconditioning through the FDA 766 process or expert guidance on regulatory compliance, our team has the expertise to minimize delays and protect your bottom line. Contact us today to resolve your DWPE issues quickly and confidently.
I Received an FDA Notice of Action. Now What?
Companies often learn their shipment has been flagged for detention without physical examination (DWPE) through an FDA Notice of Action (NOA). This notice provides critical details required to initiate the process of securing your product’s release, 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
Get Your Products Released From FDA Import Detention (DWPE) Now
The FDA can detain your products if they appear to be…
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- 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 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.
Respond to the 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.
The FDA allows you to provide evidence to overcome the charges or request to recondition the product to resolve the issue.
DWPE – We Can Help Get Your Products Released Quickly
The FDA import process can quickly become confusing and even intimidating. The submission of evidence to the 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)?
More than 40 years of experience in FDA detention testing
More former FDA employees than any other company
Testing done using FDA-accepted methodology
Ability to expedite the release of detained products
Nationwide sampling – we can help you no matter what port you use
Experience working with importers and overseas processors to overcome FDA detentions through the 766 process (reconditioning)
Our DWPE 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 DWPE 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 Colors
Blue #1, Blue #2, Green #3, Red #3, Red #40, Yellow #5, Yellow#6
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
A laboratory must practice current analytical and FDA methodologies to maintain its acceptance. Certified Laboratories 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…
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- 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 DWPE Testing to Get Your Shipment Released?
Contact us right away by completing the form below. Our team will respond quickly with a quote.
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: