Licenses and Certifications

Medical Device Manufacturing License

State of California Department of Public Health

Food and Drug Branch

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

 

Email

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.

Anti-Bribery Policy

ANTI-BRIBERY AND CORRUPTION POLICY

 

1. PURPOSE

 

Whoever we may deal with, and wherever we may operate, we are committed to doing so lawfully, ethically and with integrity. As part of this commitment, all forms of bribery and corruption are unacceptable and will not be tolerated. We must not, and we must ensure that any third party acting on our behalf does not, act corruptly in our dealings with any other person.

 

This anti-bribery and corruption policy (this “policy”) sets out the policies of the Golden West companies (the “Company”) to prevent acts of bribery and corruption. These policies and procedures have been designed to comply with legislation governing bribery and corruption on a global basis.

 

This policy provides guidance on the standards of behavior to which we must all adhere and most of these reflect the common sense and good business practices that we all work to in any event. This policy is designed to help you to identify when something is prohibited so that bribery and corruption is avoided, and provide you with help and guidance if you are unsure about whether there is a problem and you need further advice.

 

2. WHO THIS POLICY APPLIES TO

 

The fundamental standards of integrity under which we operate do not vary depending on where we work or who we are dealing with. This policy applies to all officers, employees (full and part time) and temporary workers (such as consultants or contractors) (together referred to as “employees” in this document) across the Company no matter where they are located or what they do. It is the responsibility of each of us to ensure that we comply with these standards in our daily working lives. This policy sets out a single standard that all employees must comply with, regardless of whether local law or practices might permit something to the contrary.

 

Part of the Company’s commitment to prevent bribery and corruption is to ensure that the people acting on our behalf also do so in compliance with effective anti-bribery and corruption policies. Accordingly, where we engage third parties such as agents, distributors or joint venture partners, we have obligations to complete sufficient due diligence when entering into arrangements to ensure that they are not acting corruptly, and to periodically monitor their performance to ensure ongoing compliance. In short, if we can’t do it, neither can they.

 

Failure to comply with this policy, whether or not this is intentional, may lead to disciplinary action (up to and including dismissal), and criminal liability for the individual involved (up to and including imprisonment). Employees will be required to confirm that they have read and understood the policy and that they comply with its terms as part of their ongoing employment assessment processes. In addition, relevant employees will be required to attend training to support the guidance in this policy.

 

3. BRIBERY

 

Bribery involves the following:

  • When a financial or other advantage is offered, given or promised to another person with the intention to induce or reward them or another person to perform their responsibilities or duties improperly (it does not have to be the person to whom the bribe is offered that acts improperly); or

  • When a financial or other advantage is requested, agreed to be received or accepted by another person with the intention of inducing or rewarding them or another person to perform their responsibilities or duties inappropriately (it does not have to be the person who receives the bribe that acts improperly).

 

It does not matter whether the bribe is given or received directly or through a third party (such as someone acting on the Company’s behalf, for example an agent, distributor, supplier, joint venture partner or other intermediary); or for the benefit of the recipient or some other person.

 

Bribes can take many forms, for example:

 

  • Money (or cash equivalent such as loans or opportunities to buy direct shares (i.e., “friends and family shares”) in a company with a connection to the Company);

  • Unreasonable gifts, entertainment, prizes or hospitality (e.g., payment of travel, hotel, meals, living expenses, or costs of trips or resort stays);

  • Kickbacks;

  • Favorable terms on a product or service or product discounts;

  • Unwarranted rebates or excessive commissions (e.g., to sales agents or marketing agents);

  • Unwarranted allowances or expenses;

  • “Facilitation” payments/payments made to perform their normal job more quickly and/or prioritize a particular customer;

  • Political/charitable contributions;

  • Employment offers or promises of future employment (to an individual or any of his/her relatives);

  • Uncompensated use of company services or facilities;

  • Services, personal favors, home improvements, use of vehicles or vacation homes, or discounted or free tickets to events; or

  • Anything else of value.

 

This policy applies to both the public and private sectors. Dealing with public officials poses a particular high risk in relation to bribery and corruption and specific guidance when dealing with public officials is set out below.

 

A breach of bribery laws can result in fines for both the company and the individual involved and, in some jurisdictions, could also result in imprisonment.

 

How do I know if something is a bribe? In most circumstances, common sense will determine when a bribe is being offered. However, here are some questions you should ask yourself if in doubt:

 

  • Am I being asked to pay something or provide any other benefit over and above the cost of the services being performed, for an example an excessive commission, a lavish gift, a kickback or make a contribution to a charity or political organization?

  • Am I being asked to make a payment for services to someone other than the service provider?

  • Are the hospitality or gifts I am giving or receiving reasonable and justified? Would I be embarrassed to disclose them?

  • When a payment or other benefit is being offered or received, do I know or suspect it is to induce or reward favorable treatment, to undermine an impartial decision-making process or to persuade someone to do something that would not be in the proper performance of their job?

 

4. POLICIES AND PROCEDURES

 

A. General Prohibition

 

All forms of bribery and corruption are prohibited. We will not tolerate any act of bribery or corruption. Any breach of this policy or local law could result in disciplinary action being taken and ultimately could result in dismissal. A bribe does not actually have to take place—just promising to give a bribe or agreeing to receive one is prohibited. Bribery is prohibited when dealing with any person whether they are in the public or private sector and the provisions of this policy are of general application. However, many countries have specific controls regarding dealing with public officials and this policy includes specific requirements in these circumstances.

 

B. Gifts, Hospitality and Expenses

 

Giving or receiving gifts or hospitality is often an important part of maintaining and developing business relationships. However, all gifts, hospitality and expenses should be for a genuine purpose, reasonable, given in the ordinary course of business and should comply with this policy, and local laws.

 

Lavish or unreasonable gifts or hospitality, whether these are given or received, are unacceptable as they can create the impression that we are trying to obtain or receive favorable business treatment by providing individuals with personal benefits. In addition, gifts and hospitality can themselves be a bribe. Be careful to avoid even the appearance that the giving or accepting of gifts or hospitality might influence the decisions you take on behalf of the Company.

 

C. Facilitation Payments

 

All facilitation payments are generally prohibited. However, your safety is our primary concern and we understand that there may be circumstances in which you have no alternative but to make a facilitation payment in order to protect against loss of life, limb or liberty. Any request for a facilitation payment should be reported to your local anti-bribery and corruption officer.

 

D. Agents, Distributors, Suppliers and Joint Venture Partners

 

The Company could be liable for the acts of people that act on our behalf. This includes agents, distributors, suppliers and joint venture partners (together referred to as “third parties”). As such we are committed to promoting compliance with effective anti-bribery and corruption policies by all third parties acting on behalf of the Company.

 

All third parties should be made aware of the terms of the Company’s Third Party Code of Conduct and of their obligations to comply with it. All arrangements with third parties should be subject to clear contractual terms including specific provisions requiring them to comply with minimum standards and procedures in relation to bribery and corruption. Appropriate wording to be included in contracts can be obtained from the Company’s Legal Department.

 

You must not engage any third party who you know or reasonably suspect of engaging in bribery.

 

Appropriate due diligence should be undertaken before any third parties are engaged. The appropriate level of due diligence will vary depending on the circumstances and you should use your judgement on a case by case basis.

 

Questions you should be asking yourself include:

 

  • Who are they—have I seen documents evidencing that they are who they say they are?

  • Who else have they worked with—do they have references?

  • Are they well established with a good reputation or are they more obscure so that I need to do more to find out about them?

  • Do they operate in a territory where bribery is prevalent?

  • Are they happy to sign a contract agreeing to comply with anti-bribery procedures?

  • Do they have their own anti-bribery program?

  • Have I done basic searches such a Google searches, business directory searches, etc.?

  • Are there inconsistencies between the provider of the services and the person I am paying?

  • Are commissions/payments in line with generally accepted market practice?

 

Some high risk transactions will require further due diligence which may require independent investigation.

 

Employees will be provided with helpful guidance and checklists where appropriate to support the due diligence process.

 

Entering into any joint venture arrangement without prior approval from the Company’s Legal Department is prohibited.

 

All payments and commissions to third parties must:

 

  • Be made in accordance with the Company’s policies and procedures relating to authorization and the local policies relevant in your business as set by your line manager;

  • Be made via bank transfer through the accounts payable system and be fully accounted for;

  • Be in line with generally accepted rates and business practice for the service in question and should not be unjustifiably excessive or unsupportable; and

  • Be made in accordance with the terms of the contract with the person or company providing the services.

 

If you have any concerns that arrangements with a third party are not in accordance with this policy, you should ask your local anti-bribery and corruption officer for help.

 

E. Dealing with Public Officials

 

Although this policy applies to both public and private sectors, dealing with public officials poses a particularly high risk in relation to bribery due to the strict rules and regulations in many countries. Public officials include those in government departments, but also employees of government owned or controlled commercial enterprises, international organizations, political parties and political candidates. The provision of money or anything else of value, no matter how small, to any public official for the purpose of influencing them in their official capacity is prohibited.

 

The prior approval of your local anti-bribery and corruption officer is required in relation to:

 

  • Any payment in respect of fees, salary or commission (this does not include official fees);

  • Gifts and hospitality; and

  • Making charitable contributions in connection with dealings with a public official.

 

In addition, many public officials have their own rules regarding the acceptance of gifts and hospitality, etc., and we must respect these rules where applicable.

 

F. Whistleblowing

 

The Company is committed to ensuring that employees can speak up with confidence if they have any concerns or need to ask for help. If you suspect or observe anything that you think might be in contravention of this policy, you have an obligation to report it. You should raise your concerns with Tammy Guenthner (CEO of Golden West BioSolutions LLC and Golden West Diagnostics LLC). Alternatively, you can report your concerns under the Company’s Whistleblowing Policy.

 

The Company will not tolerate retaliation in any form against anyone for raising concerns or reporting what they genuinely believe to be improper, unethical or inappropriate behavior. All reports will be treated confidentially.