Conducting Entry Review
What commodity requires Prior Notice? If a product offered for manual entry is human ___ or animal ___/___, is prior notice still required?
Food; Human Food; Animal Food/Feed; Yes
Work should be setup in accordance with?
Agency priorities, work plans, SCOPE, and assignments.
What are types of compliance generated assignments?
IB Assignments, Relabel or Reconditioning, Refusal Verification (RRV) - Exportations or Destructions, Audit Samples
1. Failure to hold - means that the goods have been distributed by the importer/consignee without an FDA release from import status. *Please note that this is defined as distribution without a release, not merely moving the goods outside of the port area.
2. Substitution - is an attempt by the importer or importer’s agent to present goods to the FDA as corresponding to a particular entry when they are, in fact, not the goods from that entry. FDA personnel may encounter this situation at various points in the importation process, including initial exam/inspection, sample collection, audit sample collection, reconciliation examination after a health hazard finding, verification of a reconditioning, and redelivery examination. Substitution may occur as an attempt to hide distribution without FDA release (Failure to Hold). The investigation may reveal negligence, gross negligence, or fraud.
3. Importer Misdeclaration -
refers to the importer’s provision of incorrect and/or incomplete information to the FDA and CBP, usually via the filer. When FDA personnel encounter this situation, it is usually during the initial examination or sampling of the entry. It may be the case that the investigation reveals negligence, gross negligence, or fraud. The following are examples of this kind of activity: 1. The importer provides information to the filer that does NOT include a product that is present in the entry, and as a result, that product is not included in the declaration (undeclared goods). 2. The importer provides the filer information that a product is manufactured by firm X, when it is, in fact, manufactured by firm Y. As a result, the filer declares the product as manufactured by firm X (misdeclared goods).
4. Filer Misdeclaration - this section is oriented to filer interventions, it must always be recognized that the filer is the agent of the importer, and the importer is ultimately responsible. Filer misdeclaration refers to the importer’s provision of correct information to the filer who then files an erroneous entry to CBP. The following are examples of this activity: 1. The filer omits a product properly listed on the entry invoice from the declaration (undeclared goods). 2. The importer provides the filer information that a product is manufactured by firm X, but the filer declares it as manufactured by firm Y (mis-declared goods). 3. The importer provides an invoice to the filer that lists product X, but the filer declares product Y. When FDA personnel encounter this situation, it is usually during the initial examination or sampling of the entry (mis-declared goods). 4. The filer selects a food Process Identification Code (PIC) for packaged food (which should only be selected when no other PIC applies, per the instructions of the FDA’s Product Code Builder on the Web) when the broker does not have sufficient information to determine if any other PIC applies (misdeclared goods).
What data elements are reviewed during a filer evaluation?
Country, Manufacturer, Product Code, Shipper, Quantity and Value (if transmitted), Affirmations of Compliance (if transmitted), and importer product descriptions.
Are CBP Forms 3461 and 7501 required for electronic entry submission in ACE? Are CBP Forms 3461 and 7501 required for Non-ABI or paper entries?
No; Yes
Does rescinding a may proceed reopen the condition release period? When should a MPro rescind be issued? What steps should be taken following a MPro rescind action?
No; should only occur for articles that are subject to compliance action, or in other exception cases; 1. obtain SCSO approval to rescind the MPro, 2. Notify the filer immediately that the MPro has been rescinded and that the line is pending an FDA admissibility decision, 3. Generate an updated NoA and forward it to the filer, importer of record, and consignee within 24 hours of rescinding the MPro., 4. Send request to CBP within 24 hours of rescinding the MPro to Unset/Hold the CBP Bond from liquidating in case CB needs to pursue a liquidated damages case against the bond for cargo that the FDA has refused and has been redelivered for export of destruction., 5. ABI codes to indicate “PGA Decision Rescinded-Do Not Distribute Product” and “May Proceed Rescinded-Hold for Further Information From PGA” are sent to the filer., 6. If the shipment has been distributed, notify CBP and request that they issue a demand for redelivery. 7. Record your process and communications with CBP in the Entry Remarks and/or Miscellaneous Info Received field in FDA systems to document follow-up when FDA issues a May Proceed inadvertently.
When a entry has been detained and a Notice of FDA Action - Detained has been issued, how many working days are allowed for the respondent to follow-up (hearing period)? What must the respondent submit during the hearing period?
10 working days is standard and is signified on the NOA as the 'respond by date'. However, this time can be extended. ; must present evidence supporting admissibility of the article, can outright request refusal of admission, or propose an effective manner of reconditioning, or other method to remove the product from the authority of the FD&C Act.
What two documents may be written by an import investigator to outline the events of an import investigation?
Investigational Memo or Affidavit
What are the number of entry lines to be reviewed for small and medium filers? What are the number of entry lines to be reviewed for large and super filers? What is the date range that the filer evaluation should focus in on (entries submitted over the last ___ months)?
50 lines; 100 lines; 12 months
Note: 40% of the lines should be disclaimed and 60% of the lines should be entry lines transmitted to FDA.
True or False; Documents received via ITACS are given priority over documents received via other means.
True
PODS is broken into how many distinct programs within the Agency? What are they? What does PODS information tell you?
6; Animal drugs and feed (CVM)..Biologics (CBER)..Human Drugs (CDER)..Medical Devices and Radiological Health (CDRH)..Tobacco Products (CTP); PODS information tells you what is done, specific task or assignment, who performed the operation, district, and collecting district.
Once an investigator has conducted the investigation and forwards the evidence collected to Compliance Branch then on to CBP, what title 19 sanctions are available to be taken and/or enforced?
authorities for administrative seizures, civil money penalties, revocation of conditional release privileges, and bond actions (including liquidated damages, increases to bond amount, and requirement of single transaction bond).
Note:
Single Transaction Bond vs. Continuous Bond
Both are customs bonds required by U.S. Customs and Border Protection for importing into the U.S.
Single Transaction Bond (STB): Covers one shipment only, Expires after that entry clears customs, Purchased per import, Cost: $50–100 minimum, based on shipment value + duties/taxes, Best for: Occasional or one-time importers
Continuous Bond (CB): Covers unlimited shipments for 1 year, Renews annually, Cost: ~$400–500 per year, Minimum bond amount: $50,000, Best for: Regular importers (3–4+ shipments per year)
Bottom Line: If you import more than a few times a year, a continuous bond is usually more cost-effective.
What office has primary responsibility for all criminal investigations conducted by FDA, including the importation of unlawful FDA-regulated products?
OCI - Office of Criminal Investigations
Note: Unlawful FDA-regulated products encountered during the importation process may serve as criminal evidence. OCI may generally take possession of such products for evidentiary purposes only after they have gone through the FDA regulatory process for refusal of admission and are subject to destruction; or after they have undergone CBP’s administrative seizure and forfeiture process.
What are the classifications for filer evaluations and FSVP evaluations?
NAI, VAI, OAI
If after review of the entry documents, they do not provide sufficient information to make an admissibility decision, the reviewer may follow up by one of the following means?
1. Direct communication (an email and/or phone call) with the filer or importer
2. Entry incomplete - Return, Deficient Entry (DFE) Entry Option
3. Request Information (INF) Activity
Explain the difference between field examination, label examination, sample collection.
Import Field Examination
An import field examination is an inspection conducted at a port of entry, warehouse, or other location where imported products are held before distribution in the U.S. During an import field examination, FDA investigators:
Import field examinations help FDA decide whether to allow entry, detain products for further review, or refuse entry of non-compliant goods.
Import Label Examination
An import label examination specifically focuses on reviewing the labeling of imported products to ensure compliance with U.S. requirements. This includes examining:
Import label examinations are critical because labeling requirements often differ between countries, and products compliant in their country of origin may not meet U.S. standards.
Import Sample Collection
Import sample collection involves obtaining physical samples from imported shipments for laboratory analysis before the products are released into U.S. commerce. FDA collects import samples to:
Import samples are collected according to established protocols and may be analyzed at FDA laboratories. Results determine whether the shipment can proceed or must be refused entry, destroyed, or re-exported.
The memo should normally be provided to supervisory staff for endorsement within __ business days of the last investigational activity and endorsed by the supervisory staff within ___ business days.
10 business days; 5 business days.
What evidence might an import investigator collect as evidence?
Entry documents (CBP Form 3461, CBP Form 7501, Invoice, Packing List, Bill of Lading)
Pertinent distribution records
Photographs
Affidavit
What specific regulatory statute established the Foreign Supplier Verification Programs (FSVP)? Under which section of the Code of Federal Regulations (CFR) is FSVP codified?
The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add section 805 (21 U.S.C. 384a) Foreign Supplier Verification Programs. Section 805 enhanced the FDA’s authority to ensure the safety of imported food.; 21 CFR part 1, subpart L
Under conditions of the entry bond, articles may receive a conditional release by CBP, pending a final admissibility decision by the FDA. This FDA entry decision must be made prior to the end of the condition release period. How many calendars is the conditional release period? Can the conditional release period be extended? What 3 ways extends conditional release period?
30 calendar days; Yes; Written or Electronic notice must be issued informing the principal bond holder (importer of record) that the products will be examined, sampled, or detained.
Note: DRQ, DR2, DTR, DER, and INF functions DO NOT extend the conditional release period.
True or False: Upon the receipt of an application for relief (appeal for Mitigation or Cancellation of Assessed Liquidated Damages), CBP may agree to mitigate the damages assessed. However, in cases involving FDA goods, CBP does not usually mitigate unless the FDA is in full agreement with the action.
True
What are the 4 elements of proof to initiate enforcement action? Explain each element.
JIVR
JURISDICTION: refers to the legal authority FDA has to regulate specific products, activities, and entities under federal law. Derives mainly from the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also includes the Public Health Service Act, Fair Packaging and Labeling Act, and other statutes. Authority is limited to products in interstate commerce (crossing state lines or affecting interstate commerce); Foods (human food and animal feed, dietary supplements, food additivities and ingredients), Drugs (Rx and OTC, Human and Veterinary, Biologics (Vaccines, Blood and Blood Products, Cellular and gene therapies, tissue for transplant), Medical devices, Radiation-Emitting Products, Cosmetics, Tobacco
INTERSTATE COMMERCE: Documents whether the product or activity involves interstate commerce; This is critical because FDA's authority primarily derives from regulating products in interstate commerce; Would include evidence such as: products shipped across state lines, ingredients sourced from multiple states, or products intended for interstate distribution; Establishes the legal basis for FDA jurisdiction
VIOLATION: Describes the specific regulatory violation(s) identified; Would cite relevant sections of the Federal Food, Drug, and Cosmetic Act or applicable regulations; Examples: adulteration, misbranding, unapproved new drug, CGMP violations; Should be specific about what law or regulation was violated
RESPONSIBILITY: Identifies the party or parties responsible for the violation; May include: manufacturer, distributor, importer, or other entities in the supply chain; Could specify individual officers or responsible persons at a firm; Establishes accountability for corrective action or enforcement
Explain standard requirements vs. modified requirements. What products are exempt from FSVP?
Standard Requirements: 21 CFR 1.502, 1.504, 1.505, 1.506, 1.508, 1.509, 1.510
Modified Requirements: 21 CFR 1.507, 1.511, 1.512, 1.513
Juice, Fish, and fishery products subject to and in compliance with Seafood HACCP regulations, food for research, food for personal consumption, alcoholic beverages and certain ingredients for use in alcoholic beverages, food imported for processing and future export, LACF but ONLY with respect to microbiological hazards cover by other regulations, and certain meat, poultry, and egg products regulated by USDA at the time of importation.