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A discussion on the importance of ITAR registration

Whether it is distributing M16 rifles for military operatives or manufacturing landing gear components for AC-130J gunships, facilities that deal with USML Defense Articles in the United States must be compliant with and registered under the International Traffic in Arms Regulations (ITAR). 

ITAR regulates the production, sale and transport of munitions categorized under the United States Munitions List (USML).  There are 21 groupings in the USML Defense Articles including:  spacecraft, aircraft, rockets and missiles, weapons, nuclear munitions as well as technology and data.  Precision machined parts for sensitive aerospace and defense programs fall within this list of regulated items.

At AIP, we not only guarantee a quality assurance program, we are ITAR certified and registered in order to assure protection of vital United States technology assets.  Our certifications also include ISO 13485:2016 certified, AS9100D:2016 certified and FDA registered.  For the past 37 years, we have worked with leading aerospace and defense engineers and contractors to machine components for the aerospace and defense sectors.  We understand the value and necessity of being ITAR certified and registered to these customers and our country.

In this issue of our monthly blog, we discuss what it means to be ITAR certified and how it emphasizes our commitment to excellence.

Why should a plastics machining facility be ITAR certified? 

The International Traffic in Arms Regulations (ITAR) is the United States regulation that controls the manufacture, sale, and distribution of defense and space-related articles and services as defined in the United States Munitions List (USML).

Besides rocket launchers, torpedoes, and other military hardware, the list also restricts the plans, diagrams, photos, and other documentation used to build ITAR-controlled military gear. This is referred to by ITAR as “technical data”.  Under ITAR, access to physical materials and technical data related to defense and military technologies is restricted to US citizens.  

Annual Fee and Registration

The ITAR certification incurs an annual registration fee of $2,250.00 along with an application.  All companies required to register must document and keep records of their ITAR related activities and make them available for inspection upon request from DDTC.  Additionally, ITAR registered companies are required to have a formal technology control plan (TCP).

Infractions and Penalties

The basic premise of ITAR is to protect sensitive military and defense material made in the United States from any harmful activity.  Any infraction against the ITAR regulations can result in heavy fines and significant brand and reputation damage.  Additionally, noncompliance can mean the loss of business to a compliant competitor.

Fines

• Civil fines up to $500,000 per violation
• Criminal fines up to $1 million and/or 10 years imprisonment per violation

Who needs to be ITAR compliant?

Any company that handles, manufactures, designs, sells, or distributes items on the USML must be ITAR compliant. The State Department’s Directorate of Defense Trade Controls (DDTC) compiles and manages the list of companies that can deal in USML goods and services. Companies must establish their own regulations to uphold ITAR compliance. Some examples of companies and entities who must be ITAR registered and certified include the following:

• Wholesalers
• Contractors
• Distributors
• Third-party suppliers
• Computer software/hardware vendors

An example would be a steel manufacturer who machines triggers for automatic rifles specifically for the United States Military. This manufacturer is required to have ITAR registration and certification to produce this specific part of the weapon. They must also follow the guidelines and establish company regulations to align with ITAR.

As a precision plastics machining company, we work closely with companies and contractors in the aerospace and defense sector. In aerospace and defense, high-performance thermoplastics are sought after for their strength and weight-saving capabilities.

Our products machined for these industries include:

• Aircraft engines, systems and structural components
• Chemical detection devices
• Landing gear components
• Military targeting and defense sensors
• Space and Satellite devices

Our machined polymers and components for aerospace and defense must pass through rigorous quality management assurance and testing while simultaneously meeting the ITAR regulations. This helps us to ensure not only that we are meeting our own personal standards of unrivaled expertise, but that we are meeting the industry standards to create unparalleled results.

How does ITAR certification help AIP serve the aerospace and defense sectors?

At AIP, we promise “unrivaled expertise and unparalleled results”. These guiding principles have made us seek out the highest levels of certifications and industry standards for these major markets: aerospace, medical, power and energy and specialized industrial.

In order to survive the rigors of the aerospace and defense industry, AIP produces components with the utmost level of precision. These products are lightweight, radar absorbent and made to last in extreme temperatures. Additionally, they follow strict adherence to industry specifications.

We know that product durability, weight and resistance to high temperatures and corrosive materials are essential for our customers. In our commitment to quality custom plastic components for aerospace and defense industry, AIP is a certified and registered ITAR facility. We are capable of satisfying all customer DOD, NASA, and FAA quality requirements flowed down from our OEM customers.

At AIP, quality assurance is a norm not only for our customers but for ourselves. As an ITAR certified and registered facility, we are proud to offer a complex quality assurance process that focuses on product quality, fast delivery and cost-effective options.

What about AIP Precision Machining allows us to achieve ITAR Certification

“Consistency and commitment define our company,” says John MacDonald, president of AIP Precision Machining. “While management pursued and procured the means to establish the ITAR registration and certification, it is our team and their daily attention to their craft and expertise that allows us to uphold the regulations. That’s what makes us better every day at exceeding the needs of our valued customers.”

Supporting Materials

AIP’s Aerospace and Defense Capabilities

Certifications and Regulatory Resources

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A discussion on the importance of FDA registration to ensure QMS in plastics machining facilities

For businesses and facilities involved in the production and distribution of medical devices, FDA Registration is a requirement to machine or manufacture any plastic material that will be used in the United States medical market.

Therefore, if your manufacturer or machining shop is not FDA registered, start looking for a new facility with the appropriate certifications and industry standard regulations. There is no compromise on safety and quality assurance when working with plastics for critical applications.

At AIP, we not only guarantee a quality assurance program, we are FDA registered, ISO 13485:2016 certified, AS9100D:2016 certified and ITAR certified. As a precision plastics machining company with over 35 years’ experience, we have worked with medical OEMs and R&D representatives to machine critical components for the medical and specialized industrial sectors. We understand the value of a transparent QMS program through the FDA Registration.

In this issue of our monthly blog, we discuss what it means to be FDA registered and how it emphasizes our commitment to quality, safety and excellence.

Why should a plastics machining facility be FDA registered?

FDA registration is a set of mandates that regulate manufacturing operations for facilities involved in the production and distribution of medical devices in the United States. It determines whether a facility has the appropriate resources, including equipment and personnel, to perform the manufacturing operations. This registration includes an annual audit to ensure compliance with the FDA registration requirements.

This audit includes an annual registration fee for device establishments. Additionally, most facilities that are FDA registered must provide a list of devices that are made there and the activities that are performed on those devices.

As per the FDA device registration and listing, “If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo).”

The use of an unregistered device or material can be very dangerous. This means it hasn’t been listed, cleared, tested or approved by the FDA. What if the device is unsafe or ineffective for the user or client?

Learn about how to ensure sterilization and industry
standards applied to plastic machined medical applications

Additionally, using a device not listed with the FDA means there is no protection for a healthcare or wellness professional should a client have a harmful experience.

If you’re unsure if a medical device is listed with the FDA, you can search for the manufacturer in the Registration & Listing Database.

How does FDA registration help AIP serve the medical market?

At AIP, we promise “unrivaled expertise and unparalleled results”. These guiding principles have made us seek out the highest levels of certifications and industry standards for these major markets: aerospace, medical, power and energy and specialized industrial.

We know that product durability, cleanliness and safety are essential for our customers. Our FDA registration allows us to create highly precise and extremely resilient machined plastics for critical applications.

We have been successfully audited by some of the most stringent OEMs across all market sectors. Our plastics are processed with strict hygienic procedures to ensure the highest level of sanitation down to the sub-molecular level.

At AIP, quality assurance is a norm not only for our customers but for ourselves. As an FDA registered facility, we are proud to offer a complex quality assurance process that focuses on product quality, fast delivery and cost-effective options.

What about AIP Precision Machining allows us to achieve FDA Registration

“At AIP, it’s about the people and their commitment to this company as a team,” said MacDonald. “We have been FDA registered for the last 35 years, and our team consistently displays attention to maintaining the standards of this regulation on the machine shop floor. That’s what makes us better every day at meeting the needs of our valued customers.”

If you are interested in learning more about our quality assurance
program or have a machined plastic part design, reach out to our team.

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