FDA PROCESS – ENTRY REVIEWS AND EXAMS

The products imported into United States that require FDA compliance include human and animal food and medicines, medical devices, tobacco products, cosmetics and electronic products that emit radiations. When the import entries are filed by the CBP authorized customs broker, the FDA staff might select the cargo for examination and sampling.

The US Government’s Food & Drugs Administration collects samples and conducts examinations to verify if certain imported products are compliant with the FDA regulations and laws. The imported products that require FDA compliance include human and animal food and medicines, medical devices, tobacco products, cosmetics and electronic products that emit radiations.

FDA REVIEW PROCESS

During the review of the import entries filed by the authorized customs brokers, FDA may decide to inspect the cargo and an FDA exam is notified to the importer so the latter could share the cargo location for FDA inspectors to visit and examine. This is where the recommended reasonable distance from port of entry comes in (ON EXPECTING DELAYS FROM FDA REVIEW) as FDA staff of that area must physically come to the location to examine. If the cargo has been stored further away, FDA may ask for its relocation closer to or at the port.

FDA examination can be of different kinds such as:

• Label Examination
• Field Examination
• Sample Collection

Label Examination:

In label examination, a member of FDA’s compliance staff reviews the labels or labelling of the products to see if it complies with the labeling requirements. Labeling requirements vary based on whether the product is a cosmetic, drug, food product or a medical device. The Shippers importing into United States goods that are subject to FDA approval must follow the labeling regulations that are specific to the product.

Field Examination:

Savvy importers keep these possible delays and costs in mind when chalking out their schedules, so they have more time before an order is due and arrangements made for storage if need be. Another good practice is to not only be aware of these possibilities but communicate them with your buyers in advance so they can plan accordingly as well.

During a field exam, physical inspection is performed on the imported product and is used to determine various things including but not limited to:

• Quantity observed does not match the quantity declared on shipping documents
• In transit or storage damage
• Inadequate storage temperature conditions
• Rodent or insect activity
• Field tests for lead in ceramic ware
• Non-permitted food and color additives
• Product integrity, uncharacteristic odors, or spoilage
• Other questionable conditions/practices

Sample Collection:

During the Field Examination, FDA can collect samples of the product to determine whether it meets public health standards. FDA investigators are trained in sampling strategies and techniques to collect samples that are representative of the product being imported and can support a final admissibility determination. The samples are sent to an FDA laboratory for analysis. The results can and do take time (sometimes months) and the product cannot be distributed or sold until results have been reviewed and final admissibility has been determined.

Product Selection for Examination & Sampling

Not every FDA regulated imported product is selected for examination and sampling. Some of the reasons for FDA selecting a cargo for examination and sampling include risk associated with the product; past violations in that product category; past violations by the manufacturer, shipper, importer; and routine surveillance.

When FDA selects the imported cargo for examination and sampling, it will notify why the shipment is being held, what needs to be done and who to contact.

If you want to learn more or have specific queries related to FDA processes, drop TEU Global (www.teuinc.com) an email at import@teuinc.com , or call us at +1 732-515-9040.