State of California Department of Public Health
Food and Drug Branch
Medical Device Manufacturing License
Licenses and Certifications
Medical Device Manufacturing License
License Number: 98755
Expiration Date: 03/23/2025
FDA Blood Establishment Registration
Food and Drug Administration
Manufacturers of Blood Products and Licensed Devices
FEI: 3013953128
DUNS: 080475629
Expiration Date: 10/09/2025
ISO 13485:2016 Certification
National Quality Assurance, U.S.A.
Quality Management Certification
ISO: 13485:2016
Certificate Number: 16596
Expiration Date: 09/11/2025
HAVE ANY QUESTIONS?
Phone
+1 (951) 699-0957
QA@goldenwestdiagnostics.com
Policies and Terms Service
Anti-Modern Slavery and Human Trafficking Statement and Policy
At Golden West Companies, we are aware of the global issue regarding modern slavery. We understand that modern slavery and human trafficking is a prevalent and real problem for millions of people around the world, including those in developed countries. Every company is at risk of being involved in this crime through its own operations and its supply chain. It is a horrible, heinous crime and is not tolerated in Golden West Companies, or in the companies that Golden West does business with.
We are committed to a work environment that is free from human trafficking and slavery, which for purposes of this statement includes forced labor and unlawful child labor. Golden West will not tolerate or condone human trafficking or slavery in any part of our organization or supply chain.
Golden West employees, subsidiaries, contractors, subcontractors, vendors, suppliers, partners and others through whom Golden West Companies conduct business must avoid complicity in any practice that constitutes trafficking in persons or slavery.
We have not been made aware of any allegations of human trafficking/slavery activities against any we do business with, but if we were, it would be immediately reported to the authorities. Employees should immediately report to management at Golden West if they become aware of any issues of trafficking/slavery at subcontractors, suppliers, partners, or others with whom Golden West does business. For more information on the U.S. Government’s policy prohibiting trafficking in persons, see 48 CFR § 52.222-50 (https://www.govinfo.gov/content/pkg/CFR-2018-title48-vol2/pdf/CFR-2018-title48-vol2-sec52-222-50.pdf).
Bioethics Policy
Golden West Diagnostics LLC (“Golden West”), who are manufacturers and distributers of raw materials for medical devices, are dedicated to upholding the highest ethical standards in all aspects of their operations. We recognize the profound impact our products have on various industries, including IVD (In Vitro Diagnostics) manufacturing, research and academic institutions, and pharmaceutical companies, as well as the well-being of individuals worldwide. As such, we are committed to conducting our business in a manner that respects the principles of bioethics, ensuring the responsible and ethical use of our products by our diverse customer base and partners.
Principles of Bioethics:
1. Safety and Well-being of End Users
a. Golden West is committed to providing materials that meet or exceed the strictest quality and safety standards to safeguard the well being of individuals and patients served by our products.
b. We will continuously monitor and improve the safety and performance of our materials to minimize risks to all those who rely on them.
2. Transparency and Accountability
a. Golden West will maintain transparent and honest communication with our customers, regulatory bodies, and the public regarding the safety, efficacy, and composition of our materials.
b. We will promptly address any product-related issues or concerns and take appropriate actions, including recalls or withdrawals, if necessary, to ensure the safety and well-being of all users.
3. Ethical Research and Development
a. We will conduct research and development activities in accordance with ethical principles, ensuring that any testing involving human subjects complies with applicable laws and regulations.
b. Our research will prioritize the development of materials that contribute to advancements in IVD, research, pharmaceuticals, and overall well-being.
4. Respect for Human Dignity and Rights
a. Golden West is committed to respecting the fundamental human rights of all individuals, including our employees, stakeholders, and those affected by our products.
b. We will not engage in or support practices that violate human dignity, such as child labor, forced labor, or discrimination, across all industries we serve.
5. Environmental Responsibility
a. We will minimize our environmental impact through responsible manufacturing processes, waste reduction, and sustainable sourcing of raw materials, benefiting both the planet and the industries we touch.
b. Golden West will strive to meet or exceed environmental regulations and support initiatives aimed at preserving our planet's health for the benefit of future generations.
6. Maintaining Privacy and Security of Personal Information
a. We will respect the privacy of personal information, including health information, that is under our control, will protect it from unauthorized uses or disclosures, and will use and release it only as necessary for our operations and as prescribed by law.
b. We will ensure that personal information that is under our control, whether in hard copy or electronic form, is maintained and transmitted in a secure manner so as to be protected from improper viewing, alteration, erasure, or exfiltration.
Implementation of ethical standards:
1. Education and training: Golden West provides comprehensive training and education to all staff, to ensure they understand and adhere to our ethical standards. Violations of this policy will be investigated and may result in disciplinary action, up to and including termination of employment or contract.
2. Regular review and revision: our bioethics policy undergoes periodic review and revision to stay current with evolving ethical norms, legal requirements, and scientific advancements.
3. Whistleblower protections: Employees and stakeholders are encouraged to report any concerns or ethical issues related to our operations. Reports can be made through established channels or anonymously, and Golden West is committed to protecting whistleblowers from retaliation.
Conclusion:
This bioethics policy reflects Golden West’s unwavering commitment to ethical conduct, the safety and well-being of individuals across diverse industries, and the betterment of the healthcare, research, academic, and pharmaceutical sectors we serve. We recognize that bioethics is a dynamic field, and we will continuously review and update this policy to align with the evolving ethical landscape and regulatory requirements. By adhering to these principles, Golden West aims to make a positive and lasting contribution to the well-being and advancement of industries and society at large.