AGQ Labs provides full-service FDA detentions support: sampling, analysis, oversight and packet submission.
- Quickest response time!
- Sampling in accordance with FDA protocols
- Fully accredited ISO/IEC 17025:2005 laboratory
- Real-time monitoring of the results (via BeSafer)
- Capability of performing analysis for over 500 pesticides and other contaminants.
- Partnered with lab to perform microbiological services for FDA detentions.
- Final Report to FDA
What are FDA Detentions?
The U.S. Food and Drug Administration (FDA) ensures imported food products meet U.S. regulatory standards. Whenever the FDA detects an unapproved chemical on a commodity, a residue exceeding the maximum residue limit, or other health hazard, the FDA deems the product to be adulterated and refuses entry into the United States. When this occurs, the supplier/product combination will be put on FDA Import Alerts and all future shipments from this supplier and product combination will be automatically detained without physical examination (DWPE). This means the FDA will refuse entry without even testing the shipment. In order for future shipments to be cleared by the FDA, a 3rd party laboratory must sample and test for the issue that put the firm and product on DWPE. The 3rd party laboratory submits their findings to the FDA and the FDA compliance officer determines if the shipment can be released.
Why AGQ Labs?
AGQ Labs provides a premier service to our customers walking them through every step of the process. From the "Notice of Action" issued by the FDA to monitoring the release of the shipment on the FDA Import Trade Auxiliary Communications System (ITACS), AGQ Labs is here to help our customers. At AGQ Labs, we understand that getting the shipment cleared as fast as possible is critical for our customers to avoid additional storage costs. This is why we strive to always submit packets prior to the first respond by date on the FDA notice of action. Unlike other labs that are only located in the U.S., AGQ Labs is an international network of laboratories that has the ability to come up with a sampling plan at origin to help ensure that shipments arriving in the U.S. are free from the contaminate that caused the issue.