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Signing Up
Do I need an account to buy Amnyo products?
Yes. We must verify provider credentials before we can ship product.
How long will it take to get verified?
It’s usually same day verification.
Shipping
Where do you ship?
We ship anywhere in the United States.
Do you ship internationally?
We can on a case-by-case basis.
Account Information
Can I change the email address on my account?
Sure thing! You can change any of the basic information you want on your account. However, if you alter the shipping address, or the provider information, we will have to re-verify your account before we can ship an order.
I forgot my password!
Click on the forgot password link on the login screen and follow the directions.
Billing
When will I be billed?
Orders are paid for directly at checkout. We do not offer delayed payment terms.
What forms of payment do you accept?
We accept all major credit cards. An ACH payment option will be available in the near future.
Website Issues
I’m having an issue checking out.
Please email us (kaylon@amnyo.com) and let us know the specific issue. If you just signed up with us we may not have completed your account verification yet.
Cancels & Returns
How can I cancel an order?
You must cancel an order before it ships. Our shipping center is in Northern Arizona and our time zone is Arizona time. We will have all shipments out the door by 2pm MST.
What is your return policy?
No returns are allowed. However we can work with you to resolve any problem that occurs.
Product & Process
How is Amnyo FDA Compliant?
According to FDA information published in late 2017 a product that is minimally manipulated, and meets homologous use requirements, meets the requirements of a section 361 biologic product. Our product is collected in it’s natural fluid state, is not over manipulated, and meets homologous use requirements for clinical use.
What processes and practices does Amnyo currently have in place to guarantee the safety and efficacy of its products?
Amnyo’s tissue processing follows FDA Good Tissue Practices (GTP), which has a focus on ensuring that the safety and efficacy of the tissues are maintained during processing. Our manufacturing, quality assurance, and final product specifications have been approved by our medical director, who is a board-certified clinical pathologist. Our tissues are tested for sterility per United States Pharmacopoeia USP <71> standards and donors are screened for communicable diseases per 21 CFR 1271.
What data does Amnyo have to support product safety and efficacy?
We have not performed any controlled clinical trials that produce specific safety and efficacy data; however, there have been no reported adverse events attributed to our products to date.
What is the source of Amnyo's amniotic fluid?
All human tissues used to manufacture our products are sourced from donors who have undergone delivery via scheduled cesarean section and who have been rigorously screened for both medical conditions and social histories. Our tissue recovery partner procures tissues with protocols that follow American Association of Tissue Banks (AATB) standards. Additionally, we have reviewed their recovery, screening, labeling, and shipping protocols and have found them acceptable.
What serology testing is conducted on donors?
Donor blood is tested for the following communicable diseases per 21 CFR 1271.
- Syphilis (STS)
- Hepatitis B Virus (Surface Ag, Core Ab, NAT)
- Hepatitis C Virus (Ab, NAT)
- Human T-lymphotropic virus, type I (Ab)
- Human T-lymphotropic virus, type II (Ab)
- Human immunodeficiency virus, type O (Ab, NAT)
- Human immunodeficiency virus, type 1 (NAT)
- Human immunodeficiency virus, type 2 (Ab)
- Cytomegalovirus (Ab)
- West Nile Virus (NAT)
Donors are also screened for social histories and high-risk behaviors that may make them a more at-risk demographic for communicable diseases.
What quality controls does Amnyo have in place to address variable collection and processing techniques by its suppliers?
Amniotic fluid is qualitatively assessed before it is accepted (i.e. for color, turbidity, fluid consistency etc.) in addition to review of the serology and social history screening results. Amnyo has partnerships with multiple amniotic fluid suppliers nationwide. Our recovery partners procure the tissues with protocols that adhere to the American Association of Tissue Banks (AATB) standards. Additionally, we have reviewed their collection protocols and have found them acceptable.
What is the average time from collection to manufacturing?
No greater than 48 hours.
Who processes Amnyo's products and how is quality controlled within the facility?
Amnyo processes their amniotic fluid products in-house at their laboratory in Flagstaff, Arizona. The lab team is led by a PhD-trained scientist with many years of biologics experience. The facility and their Quality Management System adhere to FDA Good Tissue Practices (GTP).