The FDA has the authority to conduct examinations and/or sample collections to determine if the product offered for import is in compliance with the FDA regulations and laws. As part of the entry review process, the FDA entry reviewers designate entries for examination. This examination may consist of any combination of a field examination, label examination, and/or sample collection.
- What is a label examination?
- What is a field examination?
- What is a sample collection?
- Why was my product selected for examination/sampling?
- How will the FDA notify me if my product will be examined and/or sampled?
- Can I move my product away from the port of entry before the FDA makes an admissibility decision?
- Can I distribute some of my product before the FDA conducts an examination?
- How do I verify the current status of my entry once it has been set up for examination?
- What information do I need to submit when notifying the FDA of my product’s availability for examination?
- What happens after I submit the product availability information?
- How long does examination or sampling typically take?
- What happens after an exam or sample collection and how will I be notified?
- Will the FDA provide payment for samples they collected?
- If I am entitled to payment for my samples, where do I submit the bill?
A label examination is the review of a product’s label or labeling to determine compliance with labeling requirements. The following table provides links to the labeling requirements for various product types:
|Product Type||Description||Link to Labeling Resources|
|FOOD||This section includes information on allergens, ingredients, food and color additives, food contact substances, and labeling requirements||Food Labeling|
|COSMETICS||The following are resources on cosmetic label claims, expiration dating, ingredient names (nomenclature), and related regulatory and enforcement information||Cosmetic Labeling|
|DRUGS||A searchable listing of guidance documents, including labeling for drug products||Drug Labeling|
|BLOOD AND BIOLOGICS||Advertising and labeling guidance||Blood and Biologics Labeling|
|MEDICAL DEVICES||Introduction to Medical Device Labeling||Medical Device Labeling|
|IN VITRO DIAGNOSTIC DEVICES||In Vitro Diagnostic Device Labeling Requirements||In Vitro Diagnostic Device Labeling|
A field examination is a physical inspection performed on a product. Based on a field examination, the FDA may decide to take a sample of the product and send it for analysis to an FDA laboratory, refer the product for further evaluation by the local FDA import division’s compliance branch, or release the product if no violations are found.
The examination may be conducted at various locations such as: international mail facilities, warehouses, border entry points, trucks, trains, and shipping containers.
A field examination may determine, for example:
- 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
- General label compliance
More information can be found at: FDA Investigations Operations Manual Subchapter 6.4 Field Examination
The FDA routinely collects samples of imported products to determine if the products meet public health standards. In order to accomplish this, the FDA may collect a portion of your imported product and send it to an FDA laboratory for analysis. FDA investigators are trained in sampling strategies and techniques in order to collect samples that are representative of the product being imported and can support a final admissibility determination.
More information can be found at: FDA Investigations Operations Manual Subchapter 6.5 Import Sample Collection
Below are a few reasons the FDA would conduct a physical examination or collect a sample:
- Risk associated with product
- Product history (past violations)
- Manufacturer, shipper, importer history (past violations)
- Routine surveillance
A Notice of FDA Action will be provided to the filer, importer, owner and/or consignee when the FDA decides to examine or collect a sample.
The Notice of FDA Action:
- Advises that the entry is to be held for an FDA examination or sampling; and,
- Specifies the items (lines) in the entry that need be held.
The Notice of FDA Action also identifies specific information such as the entry number, current status, why a shipment is being held, what you should do, and who to contact regarding your entry.
You may also find the status of your entry in the Import Trade Auxiliary Communication System (ITACS).
Products are not specifically required to be held at or near the port of entry prior to the FDA making an admissibility decision. However, the FDA’s expectation is that the entry process is conducted within the declared Port of Entry area. Therefore, if the FDA decides to conduct a physical examination or collect a sample and the product has been moved out of the Port of Entry area, the FDA may ask Customs and Border Protection (CBP) to issue a demand for redelivery for the products to be returned to the port of entry.
If the FDA finds that the product or a portion thereof was not held after a Notice of FDA Action has been issued and/or there was disregard of the Notice by the importer, the FDA may ask CBP to issue a demand for redelivery, meaning that the products must be returned to the port of entry. If the distributed products are not returned to CBP for FDA examination or sample collection, a bond action may be taken.
You can use your entry number at the FDA’s Import Trade Auxiliary Communication System (ITACS) page to check the status of your entry. The following are some examples of status statements you may observe in ITACS:
- Submit Entry Documents to FDA (Invoice, B/L, CBP Entry Document)
- May Proceed Without FDA Examination
- Hold All Lines - Notify FDA of Location for FDA Examination
- Hold Designated Lines - Notify FDA of Location for FDA Examination
If you have additional questions, you should contact the FDA import office at the port of entry. Visit our FDA Import Office Locations webpage for contact information.
What information do I need to submit when notifying the FDA of my product’s availability for examination?
The following information should be submitted for each entry number either through the FDA’s ITACS system or by contacting your local FDA Import office:
- Entry number
- Submitter’s name and contact information
- Complete address for location of product
- Contact name and phone number at the location
- Warehouse/storage lot number, if applicable
- Hours of operation (if known)
FDA import personnel will visit the product location to perform the examination and/or sample collection.
There are no specific statutory or regulatory requirements for the FDA to conduct its admissibility processes within a set amount of time. The FDA makes every effort to conduct activities as quickly as possible. The FDA is aware of and sensitive to the issues faced by importers when delays occur.
When a sample is collected, a Notice of FDA Action will be issued to the importer of record, consignee, and filer. This notice will provide details of the sample collection, including which products were sampled and the amount of product collected. Please visit the Regulatory Procedures Manual Chapter 9 (Notice of Sampling).
If the physical examination or analytical results indicate that the product appears to be in violation, a Notice of FDA Action (Notice of Detention and Hearing) will be issued. The product will remain on hold pending additional follow-up that will result in either the products being refused or released.
For products where the FDA does not find any apparent violations, the Notice of FDA Action will indicate the release of those products. The current status will also be transmitted electronically to the entry filer.
The FDA will pay for all physically sampled products found to be in compliance with the requirements of the Act and applicable regulations (21 CFR 1.91). In addition, the FDA will pay for samples collected by the FDA to audit private laboratory analytical results when the product is found to be in compliance. The FDA does not pay for samples taken in connection with the supervision of a reconditioning.
The FDA will not pay for a sample if the product is initially found to be in violation, even if the product is subsequently released.
You may bill the FDA office associated with the port where your product made entry. If you have questions about payment for samples, please contact the FDA Officer identified on the most recent Notice of FDA Action received.