Commitment to quality

All employees of Argonaut Manufacturing Services are thoroughly committed to the quality of our products, services, and established quality objectives. Our Quality Policy is a fundamental part of our business and is based on four pillars that include Personnel Accountability, Self-Initiative, Passion for Excellence and Trust. We are committed to maintaining the highest quality standards in the products we produce and the way we conduct ourselves – individually and as a company. The senior management team is committed to fostering an environment and culture that is quality focused and committed to continuous improvement in all areas. Argonaut partners with its clients in an open and collaborative manner to ensure that the highest standards of quality are present in the products and services we provide.

Licenses, Registrations, and ISO Certifications

Argonaut Manufacturing Services is a full service CDMO that provides products and services to innovators in multiple regulated environments. These environments include but are not limited to medical device, invitro and molecular diagnostics and drug product. Argonaut maintains multiple licenses, certifications and registrations to support our diverse customer base. Argonaut is licensed by the California Food and Drug Branch (FDB) to manufacture both medical devices and drugs at its Carlsbad, CA facilities and has been ISO 13485 certified by BSI. Links to our licensees, ISO certification and FDA registrations can be found below.

FDB Medical Device Manufacturing License

FDB Drug Manufacturing License

ISO 13485, Certificate FM 659295

FDA Registrations

Argonaut Manufacturing Services maintains a current Drug Establishment Registration and a Medical Device Registration with the U.S. Food and Drug Administration (FDA). Our FEI number is 3013508066. Links to our current FDA registrations are provided below.

Drug Establishments
Device Listings
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