Tag Archives: FTZ Regulations

Operation Silver Snake Sets CBP Field Operations Seizure Record in San Juan, Puerto Rico

Last month, the U.S. Customs and Border Protection (CBP) San Juan Field Operations announced that approximately 268 seizures were made of counterfeit products, valued at $2.4 million, which were illegally imported into Puerto Rico via international mail.  This is a record number of counterfeits seized by CBP in Puerto Rico during a single week.

A wide range of counterfeited products was seized during the week-long enforcement effort, called Operation Silver Snake, to include: consumer products, apparel, footwear, textiles, pharmaceuticals, and more.

CBP Operation SS (1)

International Mail packages are inspected by CBP to verify compliance with US laws

This is the second iteration of a week-long operation carried out in San Juan this year by the Mobile Intellectual Property Enforcement Team (MIPET), with the support of CBP’s Centers of Excellence and Expertise (CEEs), IPR-National Targeting & Analysis Group (NTAG), Homeland Security Investigations (HSI), and United States Postal Inspection Service (USPIS).

“Our dedicated CBP officers, Import Specialist, International Trade Specialists and Seized Property Specialists were key ingredients to this successful enforcement effort to protect the U.S. economy and consumers from counterfeit products,” said Edward Ryan, Assistant Director of Trade for Puerto Rico and the US Virgin Islands. “We are looking forward to conducting follow-up operations with our partners to further protect legitimate businesses and consumers from intellectual property thieves, said Ryan.

Various international mail packages inspected by CBP officers at the San Juan International Mail Branch revealed products that infringed intellectual property rights.  The products were shipped from vendors in China.

CBP protects businesses and consumers every day through an aggressive intellectual property rights (IPR) enforcement program.  CBP targets and seizes imports of counterfeit and pirated goods, and enforces exclusion orders on patent-infringing and other IPR goods.

CBP Operation SS (2)

CBP Officers label counterfeit products seized during the operation.

To effectively enforce intellectual property rights, CBP relies heavily on the cooperation of the owners of these rights. If your intellectual property is registered with the Patent and Trademark Office, the Copyright Office or the subject of a United States International Trade Commission exclusion order, you will want to inform CBP.

Information about counterfeit merchandise being illegally imported into the United States can be submitted to the CBP using an on-line tool called E-Allegation.  The e-Allegation provides a means for the public to anonymously report to CBP any suspected violations of trade laws or regulations related to the importation of goods into the U.S.

For more information about how Sentry’s import/export team can add value to your international supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Source: https://www.cbp.gov/newsroom/local-media-release/2016-07-20-000000/cbp-stops-millions-unsafe-counterfeits

Five Benefits of a Self-Directed FTZ Audit

On Thursday, April 21, 2016, Sentry BioPharma Services completed a self-directed (voluntary) inspection of the company’s foreign trade zone (FTZ) and compliance with 15 CFR Part 400.  Randall L. Higgins, Sentry’s Senior Manager of Compliance and Validation, defines five main benefits of an independent compliance evaluation as follows:

Establishes a Professional Relationship

Sentry BioPharma Services establishes a professional relationship with an experienced and specialized service provider for several reasons.  Familiarization with Sentry’s organization, employees, facility layout, policies, procedures, daily activity and compliance history facilitates the uptake of tacit knowledge.   Clear communication channels streamline response time when trouble-shooting a problem or developing a new business opportunity.  Having an established relationship also creates a new avenue for gaining important information and insight, which is especially important as new regulations evolve.

Builds Regulatory Alignment

Tapping the knowledge and experience of a foreign trade zone expert helps a company build stringent alignment with requirements of various regulatory agencies (DEA, FDA & CBP).  Normally, the specialized consultant starts with an unbiased gap analysis to test the company’s system for robustness.  This analysis offers a realistic picture of the present state of affairs.  It also simulates the way a regulatory agency may conduct an impromptu CBP inspection.  The non-threatening environment fosters collaboration to proactively reveal unknown deficiencies and opportunities for improvement.

Drives a Competitive Advantage

Teaming up with a foreign trade zone specialist serves as a competitive advantage.  The FTZ consultant identifies operational inefficiencies and offers suggestions to improve routine and in some cases repetitive tasks.  The import/export professional advice can lead to the elimination of non-value added tasks, simplification of paperwork and the reduction of redundancies.  In some cases, the objective analysis minimizes or eliminates duties, processing fees, violations, fines and penalties.

Cooperates with Administrator of the Grant of Authority

Sentry BioPharma Services’ FTZ is part of Zone 72 and is identified as subzone 011.   Sentry’s zone is located at the Indianapolis International Airport (IND) and is not considered within the customs territory of the United States.  Sentry intends to continue participation in the Federal Foreign Trade Zone program for years to come.  By voluntarily completing an internal FTZ system audit, it demonstrates Sentry’s intent to maintain a good compliance record year-after-year with its grantee.

Cultivates New Business Opportunities

The advice of a foreign trade zone consultant typically brings solutions to pain points in the pharmaceutical supply chain.  In many cases, unique problems serve as opportunities to grow the business and expand the service offering. Clients with temperature-sensitive pharmaceutical products are often looking for ways to better control the pharmaceutical supply chain.  Protecting pharmaceutical product integrity tops the list.  Also high on the list of client needs are expediting shipping and/or customs clearance requests.   Customers benefit from the added level of drug product protection which results in time-saving and overarching risk mitigation.

Mr. Randy Higgins expands, “Sentry BioPharma Services has delivered a pristine regulatory compliance record to existing and prospective clients’ year-after-year.  By embracing self-directed and independent evaluations, Sentry protects the safety, identity, strength, purity and quality (SISPQ) of the pharmaceutical products and controlled substances moving through our GMP warehouse on a daily basis.”

Sentry’s active FTZ status and customs bond support import optimization and control of temperature-sensitive biological and pharmaceutical ingredients, materials, semi-finished and finished drug products.  For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import process, contact Sentry via email or by phone at 1-866-757-7400.

https://enforcement.trade.gov/ftzpage/grantee/regs.html

International Trade